Monoclonal Antibodies
Pembrolizumab/Vibostolimab Co-Formulation for Oral Squamous Cell Carcinoma
University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente, Orange, CA
Targeting 12 different conditionsPembrolizumab/Vibostolimab Co-Formulation +11 morePhase 2RecruitingResearch Sponsored by Merck Sharp & Dohme Corp.Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
One of the following histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumors: Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, Endometrial cancer, Head and neck squamous cell carcinoma (HNSCC), Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma), Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ), Triple-negative breast cancer (TNBC), Hepatocellular carcinoma (HCC), Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, Ovarian cancer, Gastric cancer, Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator, Adequately controlled blood pressure (BP) with or without antihypertensive medications, Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART), Male participants must agree to follow contraceptive guidance, Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance, Adequate organ function.
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to approximately 5.5 years
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
Study Summary
This trial is testing a new cancer drug, given alone or with other anticancer therapies, to see if it is safe and effective in treating people with advanced solid tumors.
Eligible Conditions
- Oral Squamous Cell Carcinoma
- Endometrial Cancer
- Breast Cancer
- Gallbladder Cancer
- Cervical Cancer
- Squamous Cell Carcinoma
- Liver Cancer
- Bladder Cancer
- Ovarian Tumors
- Bile Duct Cancer
- Esophageal Cancer
- Stomach Tumors
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have one of the following types of advanced cancer: cervical, endometrial, head and neck, biliary, esophageal, breast, liver, urothelial, ovarian, or gastric cancer. You have measurable disease according to a medical assessment. Your blood pressure is controlled, and if you have HIV, it is well-managed with medication. If you are a male, you agree to follow contraceptive guidance. If you are a female, you are not pregnant or breastfeeding, and either not capable of becoming pregnant or agree to follow contraceptive guidance. Your organs are functioning adequately.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR per RECIST 1.1 as Assessed by Investigator in Participants with Selected Solid Tumors
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
PFS per RECIST 1.1 as Assessed by Investigator at 12 months
+2 moreSecondary outcome measures
Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30)
Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5)
DOR per RECIST 1.1 as Assessed by Investigator
+7 moreAwards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
9Treatment groups
Experimental Treatment
Group I: Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/BevacizumabExperimental Treatment4 Interventions
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as background therapy.
Group II: Pembrolizumab/Vibostolimab Co-Formulation + PaclitaxelExperimental Treatment2 Interventions
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus paclitaxel as background therapy until meeting discontinuation criteria.
Group III: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort)Experimental Treatment2 Interventions
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 12 mg (body weight [BW] ≥60 kg) or lenvatinib 8 mg (BW <60 kg) qd until meeting discontinuation criteria.
Group IV: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort)Experimental Treatment2 Interventions
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 20 mg once daily (qd) until meeting discontinuation criteria.
Group V: Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/CisplatinExperimental Treatment2 Interventions
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus gemcitabine (until disease progression or unacceptable toxicity) and cisplatin (up to 8 cycles) as background therapy.
Group VI: Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/OxaliplatinExperimental Treatment2 Interventions
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus capecitabine and oxaliplatin as background therapy.
Group VII: Pembrolizumab/Vibostolimab Co-FormulationExperimental Treatment1 Intervention
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion every 3 weeks (Q3W) up to 35 cycles.
Group VIII: Pembrolizumab/Vibostolimab + 5-Fluorouracil + CisplatinExperimental Treatment3 Interventions
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W, plus 5-fluorouracil (5-FU), plus Cisplatin as background therapy.
Group IX: PembrolizumabExperimental Treatment1 Intervention
Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Lenvatinib
FDA approved
Fluorouracil
FDA approved
Cisplatin
FDA approved
Paclitaxel
FDA approved
Gemcitabine
2017
Completed Phase 3
~2070
Carboplatin
2014
Completed Phase 3
~6670
Docetaxel
1995
Completed Phase 4
~5620
Bevacizumab
2014
Completed Phase 4
~5320
Capecitabine
2002
Completed Phase 3
~3230
Oxaliplatin
2011
Completed Phase 4
~1990
Find a site
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,476 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,775 Previous Clinical Trials
4,984,422 Total Patients Enrolled
Medical DirectorStudy Director
Merck Sharp & Dohme LLC2,700 Previous Clinical Trials
7,989,733 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Pembrolizumab/Vibostolimab Co-Formulation been granted authorization by the FDA?
"Although clinical data demonstrates pembrolizumab/vibostolimab co-formulation is safe, it has not yet been tested for efficacy. Thus, our team at Power rated its safety a 2 on the 1 to 3 scale."
Answered by AI
How many centers are managing this trial?
"This clinical trial is being held at 15 sites, including Houston Methodist Hospital (Site 1017) in Texas, Alaska Womens Cancer Care ( Site 1016) in Anchorage, and Memorial Sloan Kettering-Commack (Site 1021) in New York."
Answered by AI
Are individuals currently able to apply for this trial?
"Clinicaltrials.gov records show that this research endeavour remains open to volunteer enrolment, having been first posted on the 16th of September 2021 and last edited on November 25th 2022."
Answered by AI
To what extent is the Pembrolizumab/Vibostolimab Co-Formulation employed as a medical treatment?
"Pembrolizumab/Vibostolimab Co-Formulation is the preferred medication for treating malignant neoplasms. Moreover, this dual formulation has also demonstrated efficacy in patients suffering from unresectable melanoma, microsatellite instability high, and rectal carcinoma."
Answered by AI
To what extent has Pembrolizumab/Vibostolimab Co-Formulation been tested in previous clinical research trials?
"Since 1997, the City of Hope Comprehensive Cancer Center has conducted 3694 clinical trials involving Pembrolizumab/Vibostolimab Co-Formulation. At present, 2429 ongoing studies are occurring in various cities around the world; Houston being one such location."
Answered by AI
What is the scope of subjects within this medical experiment?
"To adequately perform this trial, MSD Corp. requires 610 qualified patients; locations of enrolment include Houston Methodist Hospital (Site 1017) and Alaska Womens Cancer Care ( Site 1016)."
Answered by AI
With what aims has this experiment been designed?
"The primary purpose of this trial is to evaluate Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR over the course of two years. To gauge success, researchers will also assess Duration of Response (DOR), defined as time from confirmed CR or PR until PD or death according to RECIST 1.1 criteria, and Objective Response Rate (ORR). All measurements are evaluated with the aid of an investigator following RECIST standards."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Princess Margaret Cancer Centre ( Site 1056)
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
My mother in law is having an advanced metastatic cancer of an endometrial origin. She is currently struggling with RBC’s count so I was not sure if this means her organs are functional (hence my reply with ‘unsure’).
Patient
What questions have other patients asked about this trial?
How long screening visits will take?
Patient