University of Arkansas for Medical Sciences
RecruitingLittle Rock, Arkansas, 72205, United States
CLINICAL STUDY · NCT06589804
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
RecruitingPhase 3Interventional
Sponsored by National Cancer Institute (NCI)
- Condition
- Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Refractory Head and Neck Squamous Cell Carcinoma, Refractory Hypopharyngeal Squamous Cell Carcinoma, Refractory Laryngeal Squamous Cell Carcinoma, Refractory Oral Cavity Squamous Cell Carcinoma, Refractory Oropharyngeal Squamous Cell Carcinoma, Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Study locations
- 200 reported sites
- Study updated
- 19 Oct 2026
- Source
- ClinicalTrials.gov
Overall study status is shown above. Individual hospitals may have a different recruitment status.
THE STUDY
About this study
This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.
Full official title
Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease
Detailed description
PRIMARY OBJECTIVE:
I. To assess whether the combination of cetuximab and pembrolizumab (arm 2) compared to pembrolizumab alone (arm 1) results in improved overall survival (OS) in subjects with platinum refractory HNSCC.
SECONDARY OBJECTIVES:
I. To compare pembrolizumab + cetuximab (arm 2) versus (vs.) pembrolizumab alone (arm 1) with respect to objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
II. To compare pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1) with respect to progression free survival (PFS) per RECIST 1.1.
III. To evaluate pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1) with respect to duration of response (DOR) per RECIST 1.1.
IV. To assess the safety and tolerability of pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1).
V. To assess the patient-reported toxicity using Patient Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) of pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1).
EXPLORATORY OBJECTIVES:
I. To identify specific mutational changes that may be indicative of clinical response to pembrolizumab + cetuximab and pembrolizumab alone.
II. To evaluate circulating tumor-derived deoxyribonucleic acid (ctDNA) kinetics over the course of treatment in response to pembrolizumab + cetuximab and pembrolizumab alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.
ARM 2: Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1, 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.
After completion of study treatment, patients are followed up within 4 weeks and then every 3 and/or 6 months for up to 5 years.
I. To assess whether the combination of cetuximab and pembrolizumab (arm 2) compared to pembrolizumab alone (arm 1) results in improved overall survival (OS) in subjects with platinum refractory HNSCC.
SECONDARY OBJECTIVES:
I. To compare pembrolizumab + cetuximab (arm 2) versus (vs.) pembrolizumab alone (arm 1) with respect to objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
II. To compare pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1) with respect to progression free survival (PFS) per RECIST 1.1.
III. To evaluate pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1) with respect to duration of response (DOR) per RECIST 1.1.
IV. To assess the safety and tolerability of pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1).
V. To assess the patient-reported toxicity using Patient Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) of pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1).
EXPLORATORY OBJECTIVES:
I. To identify specific mutational changes that may be indicative of clinical response to pembrolizumab + cetuximab and pembrolizumab alone.
II. To evaluate circulating tumor-derived deoxyribonucleic acid (ctDNA) kinetics over the course of treatment in response to pembrolizumab + cetuximab and pembrolizumab alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.
ARM 2: Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1, 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.
After completion of study treatment, patients are followed up within 4 weeks and then every 3 and/or 6 months for up to 5 years.
PARTICIPATION
Who may participate
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex eligibility
- All sexes
- Healthy volunteers
- Not accepted
Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.
Full inclusion and exclusion criteria
Inclusion Criteria:
* Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).
* Previously untreated for recurrent and/or metastatic disease incurable by local therapies.
* Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.
* Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.
* Measurable disease.
* Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.
* Patient must have a combined positive score PD-L1 positive (CPS \>/= 1) tumor.
* Any radiation therapy must be completed \>= 10 days prior to registration.
* Patients should not have received any prior treatment in the recurrent or metastatic setting.
* Prior therapy with neoadjuvant or induction anti PD-1/PD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was \>= 26 weeks prior to registration without evidence of disease progression during that treatment period.
* Patient has not received a live vaccine within 30 days prior to registration.
* Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).
* Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.
* Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH).
* Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3.
* Platelet count ≥ 100,000/mm\^3.
* Hemoglobin (Hgb) ≥ 9 g/dL (if \< 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL).
* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula for participant with creatinine levels \> 1.5 x institutional ULN.
* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin \< ULN for participant with total bilirubin \> 1.5 x institutional ULN.
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x ULN unless liver metastases are present in which case \< 5.0 x ULN.
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
* Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
* For treated/stable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
* Patients does not have a history of active myocarditis.
* Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.
* Patient does not have a history of solid organ transplantation.
* Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).
* Previously untreated for recurrent and/or metastatic disease incurable by local therapies.
* Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.
* Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.
* Measurable disease.
* Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.
* Patient must have a combined positive score PD-L1 positive (CPS \>/= 1) tumor.
* Any radiation therapy must be completed \>= 10 days prior to registration.
* Patients should not have received any prior treatment in the recurrent or metastatic setting.
* Prior therapy with neoadjuvant or induction anti PD-1/PD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was \>= 26 weeks prior to registration without evidence of disease progression during that treatment period.
* Patient has not received a live vaccine within 30 days prior to registration.
* Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).
* Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.
* Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH).
* Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3.
* Platelet count ≥ 100,000/mm\^3.
* Hemoglobin (Hgb) ≥ 9 g/dL (if \< 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL).
* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula for participant with creatinine levels \> 1.5 x institutional ULN.
* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin \< ULN for participant with total bilirubin \> 1.5 x institutional ULN.
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x ULN unless liver metastases are present in which case \< 5.0 x ULN.
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
* Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
* For treated/stable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
* Patients does not have a history of active myocarditis.
* Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.
* Patient does not have a history of solid organ transplantation.
NEAR YOU
Study locations worldwide
200 sitesCheck the individual site’s status and contact the listed study team for current availability.
200 sites shown
Fremont - Rideout Cancer Center
TerminatedMarysville, California, 95901, United States
Contact details are not published in this record. Check official study record ↗
VA Palo Alto Health Care System
RecruitingPalo Alto, California, 94304, United States
UCHealth Memorial Hospital Central
RecruitingColorado Springs, Colorado, 80909, United States
Site contacts (2)
Site Public ContactContactPhone: 719-365-2406
Steven R. SchusterPrincipal investigator
Memorial Hospital North
RecruitingColorado Springs, Colorado, 80920, United States
Site contacts (2)
Site Public ContactContactPhone: 719-364-6700
Steven R. SchusterPrincipal investigator
Poudre Valley Hospital
RecruitingFort Collins, Colorado, 80524, United States
Site contacts (2)
Site Public ContactContactPhone: 970-297-6150
Steven R. SchusterPrincipal investigator
Cancer Care and Hematology-Fort Collins
RecruitingFort Collins, Colorado, 80528, United States
Site contacts (2)
Steven R. SchusterPrincipal investigator
Lutheran Hospital - Cancer Centers of Colorado
RecruitingGolden, Colorado, 80401, United States
Site contacts (2)
Site Public ContactContactEmail: peaksresearch@imail.org
Karng S. LogPrincipal investigator
UCHealth Greeley Hospital
RecruitingGreeley, Colorado, 80631, United States
Site contacts (2)
Steven R. SchusterPrincipal investigator
Medical Center of the Rockies
RecruitingLoveland, Colorado, 80538, United States
Site contacts (2)
Site Public ContactContactPhone: 970-203-7083
Steven R. SchusterPrincipal investigator
Mount Sinai Comprehensive Cancer Center at Aventura
RecruitingAventura, Florida, 33180, United States
Site contacts (2)
Mike CusnirPrincipal investigator
Mount Sinai Medical Center
RecruitingMiami Beach, Florida, 33140, United States
Site contacts (2)
Mike CusnirPrincipal investigator
Saint Alphonsus Cancer Care Center-Boise
RecruitingBoise, Idaho, 83706, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Saint Alphonsus Cancer Care Center-Caldwell
RecruitingCaldwell, Idaho, 83605, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Kootenai Health - Coeur d'Alene
RecruitingCoeur d'Alene, Idaho, 83814, United States
Site contacts (2)
John M. SchallenkampPrincipal investigator
Saint Alphonsus Cancer Care Center-Nampa
RecruitingNampa, Idaho, 83687, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Kootenai Clinic Cancer Services - Post Falls
RecruitingPost Falls, Idaho, 83854, United States
Site contacts (2)
John M. SchallenkampPrincipal investigator
Kootenai Clinic Cancer Services - Sandpoint
RecruitingSandpoint, Idaho, 83864, United States
Site contacts (2)
John M. SchallenkampPrincipal investigator
Advocate Good Shepherd Hospital
RecruitingBarrington, Illinois, 60010, United States
Site contacts (2)
Site Public ContactContactPhone: 847-842-4847
Peter J. PolewskiPrincipal investigator
University of Chicago Comprehensive Cancer Center
RecruitingChicago, Illinois, 60637, United States
Site contacts (2)
Ari J. RosenbergPrincipal investigator
Advocate Illinois Masonic Medical Center
RecruitingChicago, Illinois, 60657, United States
Site contacts (2)
Site Public ContactContactPhone: 773-296-5360
Peter J. PolewskiPrincipal investigator
AMG Crystal Lake - Oncology
RecruitingCrystal Lake, Illinois, 60014, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Carle at The Riverfront
RecruitingDanville, Illinois, 61832, United States
Site contacts (2)
Suparna ManthaPrincipal investigator
Cancer Care Specialists of Illinois - Decatur
RecruitingDecatur, Illinois, 62526, United States
Site contacts (2)
Bryan A. FallerPrincipal investigator
Decatur Memorial Hospital
RecruitingDecatur, Illinois, 62526, United States
Site contacts (2)
Bryan A. FallerPrincipal investigator
Advocate Good Samaritan Hospital
RecruitingDowners Grove, Illinois, 60515, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Carle Physician Group-Effingham
RecruitingEffingham, Illinois, 62401, United States
Site contacts (2)
Suparna ManthaPrincipal investigator
Crossroads Cancer Center
RecruitingEffingham, Illinois, 62401, United States
Site contacts (2)
Bryan A. FallerPrincipal investigator
Advocate Sherman Hospital
RecruitingElgin, Illinois, 60123, United States
Site contacts (2)
Site Public ContactContactPhone: 847-429-2907
Peter J. PolewskiPrincipal investigator
Advocate South Suburban Hospital
RecruitingHazel Crest, Illinois, 60429, United States
Site contacts (2)
Site Public ContactContactPhone: 708-799-9995
Peter J. PolewskiPrincipal investigator
AMG Libertyville - Oncology
RecruitingLibertyville, Illinois, 60048, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Condell Memorial Hospital
RecruitingLibertyville, Illinois, 60048, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Illinois CancerCare-Macomb
RecruitingMacomb, Illinois, 61455, United States
Site contacts (2)
Bryan A. FallerPrincipal investigator
Carle Physician Group-Mattoon/Charleston
RecruitingMattoon, Illinois, 61938, United States
Site contacts (2)
Suparna ManthaPrincipal investigator
UC Comprehensive Cancer Center at Silver Cross
RecruitingNew Lenox, Illinois, 60451, United States
Site contacts (2)
Ari J. RosenbergPrincipal investigator
Carle BroMenn Medical Center
RecruitingNormal, Illinois, 61761, United States
Site contacts (2)
Suparna ManthaPrincipal investigator
Carle Cancer Institute Normal
RecruitingNormal, Illinois, 61761, United States
Site contacts (2)
Suparna ManthaPrincipal investigator
Cancer Care Center of O'Fallon
RecruitingO'Fallon, Illinois, 62269, United States
Site contacts (2)
Bryan A. FallerPrincipal investigator
Advocate Christ Medical Center
RecruitingOak Lawn, Illinois, 60453-2699, United States
Site contacts (2)
Site Public ContactContactPhone: 800-323-8622
Peter J. PolewskiPrincipal investigator
Advocate Outpatient Center - Oak Lawn
RecruitingOak Lawn, Illinois, 60453, United States
Site contacts (2)
Site Public ContactContactEmail: ncorp@aah.org
Peter J. PolewskiPrincipal investigator
University of Chicago Medicine-Orland Park
RecruitingOrland Park, Illinois, 60462, United States
Site contacts (2)
Ari J. RosenbergPrincipal investigator
Advocate High Tech Medical Park
RecruitingPalos Heights, Illinois, 60463, United States
Site contacts (2)
Site Public ContactContactEmail: ncorp@aah.org
Peter J. PolewskiPrincipal investigator
Advocate Lutheran General Hospital
RecruitingPark Ridge, Illinois, 60068, United States
Site contacts (2)
Site Public ContactContactPhone: 847-384-3621
Peter J. PolewskiPrincipal investigator
Illinois CancerCare-Peoria
RecruitingPeoria, Illinois, 61615, United States
Site contacts (2)
Bryan A. FallerPrincipal investigator
UW Health Carbone Cancer Center Rockford
RecruitingRockford, Illinois, 61114, United States
Site contacts (2)
Fahrettin CovutPrincipal investigator
Memorial Hospital East
RecruitingShiloh, Illinois, 62269, United States
Site contacts (2)
Christine AuberlePrincipal investigator
Southern Illinois University School of Medicine
RecruitingSpringfield, Illinois, 62702, United States
Springfield Clinic
RecruitingSpringfield, Illinois, 62702, United States
Springfield Memorial Hospital
RecruitingSpringfield, Illinois, 62781, United States
Site contacts (2)
Bryan A. FallerPrincipal investigator
Carle Cancer Center
RecruitingUrbana, Illinois, 61801, United States
Site contacts (2)
Suparna ManthaPrincipal investigator
UChicago Medicine Northwest Indiana
RecruitingCrown Point, Indiana, 46307, United States
Site contacts (2)
Ari J. RosenbergPrincipal investigator
Mary Greeley Medical Center
RecruitingAmes, Iowa, 50010, United States
Site contacts (2)
Site Public ContactContactPhone: 515-956-4132
Joseph J. MerchantPrincipal investigator
McFarland Clinic - Ames
RecruitingAmes, Iowa, 50010, United States
Site contacts (2)
Joseph J. MerchantPrincipal investigator
McFarland Clinic - Boone
SuspendedBoone, Iowa, 50036, United States
Contact details are not published in this record. Check official study record ↗
Mercy Hospital
RecruitingCedar Rapids, Iowa, 52403, United States
Site contacts (2)
Site Public ContactContactPhone: 319-365-4673
Deborah W. WilburPrincipal investigator
Oncology Associates at Mercy Medical Center
RecruitingCedar Rapids, Iowa, 52403, United States
Site contacts (2)
Site Public ContactContactPhone: 319-363-2690
Deborah W. WilburPrincipal investigator
McFarland Clinic - Trinity Cancer Center
RecruitingFort Dodge, Iowa, 50501, United States
Site contacts (2)
Site Public ContactContactPhone: 515-956-4132
Joseph J. MerchantPrincipal investigator
McFarland Clinic - Jefferson
SuspendedJefferson, Iowa, 50129, United States
Contact details are not published in this record. Check official study record ↗
McFarland Clinic - Marshalltown
RecruitingMarshalltown, Iowa, 50158, United States
Site contacts (2)
Site Public ContactContactPhone: 515-956-4132
Joseph J. MerchantPrincipal investigator
HaysMed
RecruitingHays, Kansas, 67601, United States
Site contacts (2)
Site Public ContactContactPhone: 785-623-5774
Prakash C. NeupanePrincipal investigator
University of Kansas Cancer Center
RecruitingKansas City, Kansas, 66160, United States
Site contacts (2)
Prakash C. NeupanePrincipal investigator
Lawrence Memorial Hospital
RecruitingLawrence, Kansas, 66044, United States
Site contacts (2)
Prakash C. NeupanePrincipal investigator
The University of Kansas Cancer Center - Olathe
RecruitingOlathe, Kansas, 66061, United States
Site contacts (2)
Prakash C. NeupanePrincipal investigator
University of Kansas Cancer Center-Overland Park
RecruitingOverland Park, Kansas, 66210, United States
Site contacts (2)
Prakash C. NeupanePrincipal investigator
University of Kansas Hospital-Indian Creek Campus
RecruitingOverland Park, Kansas, 66211, United States
Site contacts (2)
Prakash C. NeupanePrincipal investigator
Salina Regional Health Center
RecruitingSalina, Kansas, 67401, United States
Site contacts (2)
Prakash C. NeupanePrincipal investigator
University of Kansas Health System Saint Francis Campus
RecruitingTopeka, Kansas, 66606, United States
Site contacts (2)
Site Public ContactContactPhone: 785-295-8000
Prakash C. NeupanePrincipal investigator
University of Kansas Hospital-Westwood Cancer Center
RecruitingWestwood, Kansas, 66205, United States
Site contacts (2)
Prakash C. NeupanePrincipal investigator
University of Maryland/Greenebaum Cancer Center
RecruitingBaltimore, Maryland, 21201, United States
Boston Medical Center
RecruitingBoston, Massachusetts, 02118, United States
Site contacts (2)
Site Public ContactContactPhone: 617-638-8265
Peter C. EverettPrincipal investigator
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RecruitingAnn Arbor, Michigan, 48106, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RecruitingBrighton, Michigan, 48114, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Trinity Health IHA Medical Group Hematology Oncology - Canton
RecruitingCanton, Michigan, 48188, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RecruitingChelsea, Michigan, 48118, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Cancer Hematology Centers - Flint
RecruitingFlint, Michigan, 48503, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Genesee Hematology Oncology PC
SuspendedFlint, Michigan, 48503, United States
Contact details are not published in this record. Check official study record ↗
Genesys Hurley Cancer Institute
RecruitingFlint, Michigan, 48503, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Hurley Medical Center
RecruitingFlint, Michigan, 48503, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
University of Michigan Health - Sparrow Lansing
RecruitingLansing, Michigan, 48912, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Trinity Health Saint Mary Mercy Livonia Hospital
RecruitingLivonia, Michigan, 48154, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Trinity Health Saint Joseph Mercy Oakland Hospital
RecruitingPontiac, Michigan, 48341, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RecruitingYpsilanti, Michigan, 48197, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Sanford Joe Lueken Cancer Center
RecruitingBemidji, Minnesota, 56601, United States
Site contacts (2)
Daniel AlmquistPrincipal investigator
Minnesota Oncology - Burnsville
RecruitingBurnsville, Minnesota, 55337, United States
Site contacts (2)
Yan JiPrincipal investigator
Mercy Hospital
RecruitingCoon Rapids, Minnesota, 55433, United States
Site contacts (2)
Yan JiPrincipal investigator
Fairview Southdale Hospital
RecruitingEdina, Minnesota, 55435, United States
Site contacts (2)
Yan JiPrincipal investigator
Saint John's Hospital - Healtheast
RecruitingMaplewood, Minnesota, 55109, United States
Site contacts (2)
Yan JiPrincipal investigator
Abbott-Northwestern Hospital
RecruitingMinneapolis, Minnesota, 55407, United States
Site contacts (2)
Yan JiPrincipal investigator
Hennepin County Medical Center
RecruitingMinneapolis, Minnesota, 55415, United States
Site contacts (2)
Yan JiPrincipal investigator
Park Nicollet Clinic - Saint Louis Park
RecruitingSaint Louis Park, Minnesota, 55416, United States
Site contacts (2)
Yan JiPrincipal investigator
Regions Hospital
RecruitingSaint Paul, Minnesota, 55101, United States
Site contacts (2)
Yan JiPrincipal investigator
United Hospital
RecruitingSaint Paul, Minnesota, 55102, United States
Site contacts (2)
Yan JiPrincipal investigator
Saint Francis Medical Center
RecruitingCape Girardeau, Missouri, 63703, United States
Site contacts (2)
Bryan A. FallerPrincipal investigator
Siteman Cancer Center at Saint Peters Hospital
RecruitingCity of Saint Peters, Missouri, 63376, United States
Site contacts (2)
Christine AuberlePrincipal investigator
Siteman Cancer Center at West County Hospital
RecruitingCreve Coeur, Missouri, 63141, United States
Site contacts (2)
Christine AuberlePrincipal investigator
University Health Truman Medical Center
RecruitingKansas City, Missouri, 64108, United States
Site contacts (2)
Site Public ContactContactPhone: 816-404-4375
Prakash C. NeupanePrincipal investigator
University of Kansas Cancer Center - Briarcliff
RecruitingKansas City, Missouri, 64116, United States
Site contacts (2)
Site Public ContactContactPhone: 913-588-3671
Prakash C. NeupanePrincipal investigator
University of Kansas Cancer Center - North
RecruitingKansas City, Missouri, 64154, United States
Site contacts (2)
Prakash C. NeupanePrincipal investigator
University of Kansas Cancer Center - Lee's Summit
RecruitingLee's Summit, Missouri, 64064, United States
Site contacts (2)
Prakash C. NeupanePrincipal investigator
Liberty Hospital
RecruitingLiberty, Missouri, 64068, United States
Site contacts (2)
Site Public ContactContactPhone: 913-588-1569
Prakash C. NeupanePrincipal investigator
Lake Regional Hospital
RecruitingOsage Beach, Missouri, 65065, United States
Site contacts (2)
Jay W. CarlsonPrincipal investigator
Washington University School of Medicine
RecruitingSt Louis, Missouri, 63110, United States
Site contacts (2)
Christine AuberlePrincipal investigator
Mercy Hospital South
RecruitingSt Louis, Missouri, 63128, United States
Site contacts (2)
Jay W. CarlsonPrincipal investigator
Siteman Cancer Center-South County
RecruitingSt Louis, Missouri, 63129, United States
Site contacts (2)
Christine AuberlePrincipal investigator
Siteman Cancer Center at Christian Hospital
RecruitingSt Louis, Missouri, 63136, United States
Site contacts (2)
Christine AuberlePrincipal investigator
Community Hospital of Anaconda
RecruitingAnaconda, Montana, 59711, United States
Site contacts (2)
John M. SchallenkampPrincipal investigator
Billings Clinic Cancer Center
RecruitingBillings, Montana, 59101, United States
Site contacts (2)
John M. SchallenkampPrincipal investigator
Bozeman Health Deaconess Hospital
RecruitingBozeman, Montana, 59715, United States
Site contacts (2)
John M. SchallenkampPrincipal investigator
Benefis Sletten Cancer Institute
RecruitingGreat Falls, Montana, 59405, United States
Site contacts (2)
John M. SchallenkampPrincipal investigator
Logan Health Medical Center
RecruitingKalispell, Montana, 59901, United States
Site contacts (2)
John M. SchallenkampPrincipal investigator
Community Medical Center
RecruitingMissoula, Montana, 59804, United States
Site contacts (2)
John M. SchallenkampPrincipal investigator
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RecruitingLebanon, New Hampshire, 03756, United States
Site contacts (2)
Joerg RathmannPrincipal investigator
Memorial Sloan Kettering Basking Ridge
RecruitingBasking Ridge, New Jersey, 07920, United States
Jefferson Cherry Hill Hospital
Active, not recruitingCherry Hill, New Jersey, 08002, United States
Contact details are not published in this record. Check official study record ↗
Memorial Sloan Kettering Monmouth
RecruitingMiddletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
RecruitingMontvale, New Jersey, 07645, United States
Sidney Kimmel Cancer Center Washington Township
Active, not recruitingSewell, New Jersey, 08080, United States
Contact details are not published in this record. Check official study record ↗
Memorial Sloan Kettering Commack
RecruitingCommack, New York, 11725, United States
Glens Falls Hospital
Active, not recruitingGlens Falls, New York, 12801, United States
Contact details are not published in this record. Check official study record ↗
Memorial Sloan Kettering Westchester
RecruitingHarrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
RecruitingNew York, New York, 10065, United States
State University of New York Upstate Medical University
RecruitingSyracuse, New York, 13210, United States
SUNY Upstate Medical Center-Community Campus
RecruitingSyracuse, New York, 13215, United States
Memorial Sloan Kettering Nassau
RecruitingUniondale, New York, 11553, United States
Upstate Cancer Center at Verona
RecruitingVerona, New York, 13478, United States
Site contacts (2)
Komal AkhtarPrincipal investigator
UNC Lineberger Comprehensive Cancer Center
RecruitingChapel Hill, North Carolina, 27599, United States
Site contacts (2)
Siddharth ShethPrincipal investigator
Margaret R Pardee Memorial Hospital
RecruitingHendersonville, North Carolina, 28791, United States
Site contacts (2)
John K. HillPrincipal investigator
FirstHealth of the Carolinas-Moore Regional Hospital
RecruitingPinehurst, North Carolina, 28374, United States
Site contacts (2)
Charles S. KuzmaPrincipal investigator
Sanford Bismarck Medical Center
RecruitingBismarck, North Dakota, 58501, United States
Site contacts (2)
Daniel AlmquistPrincipal investigator
Sanford Broadway Medical Center
RecruitingFargo, North Dakota, 58122, United States
Site contacts (2)
Daniel AlmquistPrincipal investigator
Sanford Roger Maris Cancer Center
RecruitingFargo, North Dakota, 58122, United States
Site contacts (2)
Daniel AlmquistPrincipal investigator
Miami Valley Hospital South
RecruitingCenterville, Ohio, 45459, United States
Site contacts (2)
Tarek M. SabaghPrincipal investigator
Miami Valley Hospital
RecruitingDayton, Ohio, 45409, United States
Site contacts (2)
Tarek M. SabaghPrincipal investigator
Miami Valley Hospital North
RecruitingDayton, Ohio, 45415, United States
Site contacts (2)
Tarek M. SabaghPrincipal investigator
Atrium Medical Center-Middletown Regional Hospital
RecruitingFranklin, Ohio, 45005-1066, United States
Site contacts (2)
Tarek M. SabaghPrincipal investigator
Miami Valley Cancer Care and Infusion
RecruitingGreenville, Ohio, 45331, United States
ProMedica Flower Hospital
RecruitingSylvania, Ohio, 43560, United States
Site contacts (2)
Chang XiaPrincipal investigator
Upper Valley Medical Center
RecruitingTroy, Ohio, 45373, United States
Site contacts (2)
Tarek M. SabaghPrincipal investigator
Cancer Centers of Southwest Oklahoma Research
RecruitingLawton, Oklahoma, 73505, United States
University of Oklahoma Health Sciences Center
RecruitingOklahoma City, Oklahoma, 73104, United States
Site contacts (2)
Minh PhanPrincipal investigator
Saint Alphonsus Cancer Care Center-Ontario
RecruitingOntario, Oregon, 97914, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Providence Willamette Falls Medical Center
RecruitingOregon City, Oregon, 97045, United States
Site contacts (2)
Alison K. ConlinPrincipal investigator
Providence Portland Medical Center
RecruitingPortland, Oregon, 97213, United States
Site contacts (2)
Alison K. ConlinPrincipal investigator
Providence Saint Vincent Medical Center
RecruitingPortland, Oregon, 97225, United States
Site contacts (2)
Alison K. ConlinPrincipal investigator
Lehigh Valley Hospital-Cedar Crest
RecruitingAllentown, Pennsylvania, 18103, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Lehigh Valley Hospital - Muhlenberg
RecruitingBethlehem, Pennsylvania, 18017, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
Carlisle Regional Cancer Center
RecruitingCarlisle, Pennsylvania, 17015, United States
Site contacts (2)
Dan P. ZandbergPrincipal investigator
Pocono Medical Center
RecruitingEast Stroudsburg, Pennsylvania, 18301, United States
Site contacts (2)
Christopher M. ReynoldsPrincipal investigator
UPMC Hillman Cancer Center Erie
RecruitingErie, Pennsylvania, 16505, United States
Site contacts (2)
Dan P. ZandbergPrincipal investigator
UPMC Cancer Centers - Arnold Palmer Pavilion
RecruitingGreensburg, Pennsylvania, 15601, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
RecruitingHarrisburg, Pennsylvania, 17109, United States
Site contacts (2)
Dan P. ZandbergPrincipal investigator
IRMC Cancer Center
RecruitingIndiana, Pennsylvania, 15701, United States
Site contacts (2)
Dan P. ZandbergPrincipal investigator
UPMC-Johnstown/John P. Murtha Regional Cancer Center
RecruitingJohnstown, Pennsylvania, 15901, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
RecruitingMechanicsburg, Pennsylvania, 17050, United States
Site contacts (2)
Dan P. ZandbergPrincipal investigator
UPMC Hillman Cancer Center - Monroeville
RecruitingMonroeville, Pennsylvania, 15146, United States
Site contacts (2)
Dan P. ZandbergPrincipal investigator
Jefferson Torresdale Hospital
Active, not recruitingPhiladelphia, Pennsylvania, 19114, United States
Contact details are not published in this record. Check official study record ↗
UPMC-Saint Margaret
RecruitingPittsburgh, Pennsylvania, 15215, United States
UPMC Hillman Cancer Center
RecruitingPittsburgh, Pennsylvania, 15232, United States
UPMC-Passavant Hospital
RecruitingPittsburgh, Pennsylvania, 15237, United States
UPMC-Saint Clair Hospital Cancer Center
RecruitingPittsburgh, Pennsylvania, 15243, United States
UPMC Cancer Center at UPMC Northwest
RecruitingSeneca, Pennsylvania, 16346, United States
UPMC Cancer Center-Uniontown
RecruitingUniontown, Pennsylvania, 15401, United States
Site contacts (2)
Dan P. ZandbergPrincipal investigator
UPMC Cancer Center-Washington
RecruitingWashington, Pennsylvania, 15301, United States
Site contacts (2)
Dan P. ZandbergPrincipal investigator
Medical University of South Carolina
RecruitingCharleston, South Carolina, 29425, United States
Site contacts (2)
John M. KaczmarPrincipal investigator
Avera Cancer Institute - Mitchell
RecruitingMitchell, South Dakota, 57301, United States
Site contacts (2)
Benjamin M. SolomonPrincipal investigator
Avera Cancer Institute at Pierre
RecruitingPierre, South Dakota, 57501, United States
Site contacts (2)
Benjamin M. SolomonPrincipal investigator
Sanford Cancer Center Oncology Clinic
RecruitingSioux Falls, South Dakota, 57104, United States
Site contacts (2)
Daniel AlmquistPrincipal investigator
Avera Cancer Institute
RecruitingSioux Falls, South Dakota, 57105, United States
Site contacts (2)
Benjamin M. SolomonPrincipal investigator
Sanford USD Medical Center - Sioux Falls
RecruitingSioux Falls, South Dakota, 57117-5134, United States
Site contacts (2)
Daniel AlmquistPrincipal investigator
Avera Cancer Institute at Yankton
RecruitingYankton, South Dakota, 57078, United States
Site contacts (2)
Benjamin M. SolomonPrincipal investigator
Dartmouth Cancer Center - North
RecruitingSaint Johnsbury, Vermont, 05819, United States
Site contacts (2)
Joerg RathmannPrincipal investigator
VCU Massey Cancer Center at Stony Point
RecruitingRichmond, Virginia, 23235, United States
Site contacts (2)
Site Public ContactContactEmail: ctoclinops@vcu.edu
Erin R. AlesiPrincipal investigator
VCU Massey Comprehensive Cancer Center
RecruitingRichmond, Virginia, 23298, United States
Site contacts (2)
Erin R. AlesiPrincipal investigator
Vandalia Health/CAMC Institute for Academic Medicine
RecruitingCharleston, West Virginia, 25304, United States
Site contacts (2)
Kok Hoe ChanPrincipal investigator
Aurora Cancer Care-Southern Lakes VLCC
RecruitingBurlington, Wisconsin, 53105, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Aurora Saint Luke's South Shore
RecruitingCudahy, Wisconsin, 53110, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Marshfield Medical Center-EC Cancer Center
RecruitingEau Claire, Wisconsin, 54701, United States
Site contacts (2)
Seth O. FagbemiPrincipal investigator
Aurora Health Care Germantown Health Center
RecruitingGermantown, Wisconsin, 53022, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Aurora Cancer Care-Grafton
RecruitingGrafton, Wisconsin, 53024, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Aurora BayCare Medical Center
RecruitingGreen Bay, Wisconsin, 54311, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Aurora Cancer Care-Kenosha South
RecruitingKenosha, Wisconsin, 53142, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Gundersen Lutheran Medical Center
RecruitingLa Crosse, Wisconsin, 54601, United States
Site contacts (2)
Michael O. OjelabiPrincipal investigator
Aurora Bay Area Medical Group-Marinette
RecruitingMarinette, Wisconsin, 54143, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Marshfield Medical Center-Marshfield
RecruitingMarshfield, Wisconsin, 54449, United States
Site contacts (2)
Seth O. FagbemiPrincipal investigator
Aurora Cancer Care-Milwaukee
RecruitingMilwaukee, Wisconsin, 53209, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Aurora Saint Luke's Medical Center
RecruitingMilwaukee, Wisconsin, 53215, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Aurora Sinai Medical Center
RecruitingMilwaukee, Wisconsin, 53233, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
ProHealth D N Greenwald Center
RecruitingMukwonago, Wisconsin, 53149, United States
Site contacts (2)
Site Public ContactContactEmail: research.institute@phci.org
Timothy R. WassenaarPrincipal investigator
ProHealth Oconomowoc Memorial Hospital
RecruitingOconomowoc, Wisconsin, 53066, United States
Site contacts (2)
Site Public ContactContactPhone: 262-928-7878
Timothy R. WassenaarPrincipal investigator
Vince Lombardi Cancer Clinic - Oshkosh
RecruitingOshkosh, Wisconsin, 54904, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Aurora Cancer Care-Racine
RecruitingRacine, Wisconsin, 53406, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Vince Lombardi Cancer Clinic-Sheboygan
RecruitingSheboygan, Wisconsin, 53081, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Marshfield Medical Center-River Region at Stevens Point
RecruitingStevens Point, Wisconsin, 54482, United States
Site contacts (2)
Seth O. FagbemiPrincipal investigator
Aurora Medical Center in Summit
RecruitingSummit, Wisconsin, 53066, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Vince Lombardi Cancer Clinic-Two Rivers
RecruitingTwo Rivers, Wisconsin, 54241, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
ProHealth Waukesha Memorial Hospital
RecruitingWaukesha, Wisconsin, 53188, United States
Site contacts (2)
Site Public ContactContactPhone: 262-928-7632
Timothy R. WassenaarPrincipal investigator
UW Cancer Center at ProHealth Care
RecruitingWaukesha, Wisconsin, 53188, United States
Site contacts (2)
Timothy R. WassenaarPrincipal investigator
Aurora Cancer Care-Milwaukee West
RecruitingWauwatosa, Wisconsin, 53226, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Aurora West Allis Medical Center
RecruitingWest Allis, Wisconsin, 53227, United States
Site contacts (2)
Peter J. PolewskiPrincipal investigator
Marshfield Medical Center - Weston
RecruitingWeston, Wisconsin, 54476, United States
Site contacts (2)
Seth O. FagbemiPrincipal investigator
No centres match this search. Try another hospital, city, state or country.
WHAT IS BEING STUDIED
Treatments and study groups
Interventions
Biospecimen Collection
Undergo blood sample collection
Study groups: Arm 1 (pembrolizumab), Arm 2 (cetuximab, pembrolizumab)
Other names: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Cetuximab
Given IV
Study groups: Arm 2 (cetuximab, pembrolizumab)
Other names: C 225, C-225, C225, Cetuxa, Cetuximab Biosimilar CDP-1, Cetuximab Biosimilar CMAB009, Cetuximab Biosimilar KL 140, Cetuximab-cetu, Chimeric Anti-EGFR Monoclonal Antibody, Chimeric MoAb C225, Chimeric Monoclonal Antibody C225, ENZ 124, ENZ-124, ENZ124, Erbitux, IMC-C225
Computed Tomography
Undergo CT or PET/CT
Study groups: Arm 1 (pembrolizumab), Arm 2 (cetuximab, pembrolizumab)
Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Magnetic Resonance Imaging
Undergo MRI
Study groups: Arm 1 (pembrolizumab), Arm 2 (cetuximab, pembrolizumab)
Other names: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Pembrolizumab
Given IV
Study groups: Arm 1 (pembrolizumab), Arm 2 (cetuximab, pembrolizumab)
Other names: BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475
Positron Emission Tomography
Undergo PET/CT
Study groups: Arm 1 (pembrolizumab), Arm 2 (cetuximab, pembrolizumab)
Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Study groups
Arm 1 (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.
Interventions: Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Biological: Pembrolizumab, Procedure: Positron Emission Tomography
Arm 2 (cetuximab, pembrolizumab)
Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1, 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.
Interventions: Procedure: Biospecimen Collection, Biological: Cetuximab, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Biological: Pembrolizumab, Procedure: Positron Emission Tomography
RESEARCH DETAILS
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomized
- Study model
- Parallel
- Masking
- None (open label)
- Enrolment
- 158 participants · Estimated
TIMELINE & MEASURES
Dates and outcomes
- Study started
- 27 Mar 2025 · Actual
- Primary completion
- 25 Dec 2032 · Estimated
- Study completion
- 25 Dec 2032 · Estimated
- First registered
- 19 Sep 2024 · Actual
- Last registry update
- 19 Oct 2026 · Actual
- Status last verified
- Oct 2026
Primary outcomes (1)
Overall survival (OS)
Will be estimated using the Kaplan-Meier method. Will be based on the stratified log-rank test that will compare the distributions across the treatment arms. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well, where the multivariable Cox model will also adjust for other key baseline factors of interest. Hazard ratios and 95% confidence intervals, along with likelihood ratio p-values will be reported from these Cox models. Forest plots will be used to illustrate the comparisons between the arms within subgroups defined by stratification factors and key baseline characteristics.
Time frame: Time from randomization to death from any cause, assessed up to 5 years
Secondary outcomes (5)
Confirmed response rate
Will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria if patients have a partial or complete response for 2 consecutive evaluations at least 4 weeks apart, using local review only. The proportion of patients with a confirmed response will be calculated and compared between the 2 arms using a Chi-square or Fisher's Exact test.
Time frame: Up to 5 years
Duration of response
Will be defined for all evaluable patients who have achieved an objective response. Will be assessed per RECIST 1.1 criteria. Will be estimated using the Kaplan-Meier method.
Time frame: From the date at which the patient's earliest best objective status is first noted to be either a complete response or partial response to the earliest date progression is documented, assessed up to 5 years
Progression free survival
Disease progression will be assessed per RECIST 1.1 criteria. Will be compared between the 2 arms using the Kaplan-Meier method, where the log-rank test will be used to calculate the p-value.
Time frame: Time from randomization to the first of either disease progression or death from any cause, assessed up to 5 years
Incidence of adverse events
Will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Time frame: Up to 5 years
Patient-reported toxicity
Will be assessed using Patient-Reported Outcomes version of the CTCAE. The frequency and proportion of patients with a maximum post-baseline score greater than 0 will be compared across arms using a Chi-square or Fisher's exact test with a nominal significance level of alpha = 0.10. Similarly, the frequency and proportion of patients with a maximum post-baseline score greater than or equal to 3 will be compared across arms using a Chi-square or Fisher's exact test with a nominal significance level of alpha = 0.10. Patients' maximum baseline-adjusted scores will be calculated using the method described by Dueck et al.
Time frame: Up to 5 years
Other outcomes (3)
Estimates of median OS by sex
Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by sex.
Time frame: Up to 5 years
Estimates of median OS by race
Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by race.
Time frame: Up to 5 years
Estimates of median OS by ethnicity
Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by ethnicity.
Time frame: Up to 5 years
STUDY TEAM
Sponsor and contacts
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- Nih
- Collaborators
- Not reported
- Organisation study ID
- NCI-2024-07339
Central study contacts
No central contact is currently reported. Check the site contacts or the official record.
Study officials
Siddharth ShethPrincipal investigator · Alliance for Clinical Trials in Oncology
Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.
FURTHER READING
Results, documents and references
No results are posted in this registry record
This does not mean the study has no findings. Results may not yet have been submitted or published here.
No study documents are listed in this record.