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Monoclonal Antibodies

MK-7684A for Advanced Cancers

Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Endometrial cancer
Male participants must agree to follow contraceptive guidance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5.5 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with certain advanced solid tumors, including various carcinomas like cervical, endometrial, and esophageal cancer. Participants must not be pregnant or breastfeeding and should agree to use contraception. They need controlled blood pressure, adequate organ function, measurable disease per RECIST v1.1 criteria, and well-controlled HIV if applicable.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a drug combo called pembrolizumab/vibostolimab (MK-7684A), alone or with other cancer therapies. It aims to see if this combination works better than pembrolizumab alone in treating participants with cervical cancer by looking at response rates and survival without progression.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs, infusion-related symptoms such as fever or chills, fatigue, nausea or vomiting from chemotherapy drugs involved in the trial like cisplatin or paclitaxel; high blood pressure due to lenvatinib; plus risks associated with general anticancer treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have endometrial cancer.
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I agree to follow the study's rules for using birth control.
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My blood pressure is under control, with or without medication.
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My cancer is advanced and cannot be surgically removed.
Select...
My cervical cancer is one of the following types: squamous, adenosquamous, or adenocarcinoma.
Select...
My HIV is well controlled with medication.
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My cancer is in the esophagus or where my stomach meets my esophagus.
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I have been diagnosed with liver cancer (HCC).
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I am not pregnant, breastfeeding, and if able to bear children, I agree to use contraception.
Select...
I have been diagnosed with head and neck squamous cell carcinoma.
Select...
My cancer can be measured using standard imaging tests.
Select...
My organs are working well.
Select...
My cancer in the bile ducts or gallbladder cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5.5 years for reporting.

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 more
Secondary 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 more

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
2017
Completed Phase 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690
5-Fluorouracil
2012
Completed Phase 3
~7800
Cisplatin
2013
Completed Phase 3
~1940
Paclitaxel
2011
Completed Phase 4
~5380
Gemcitabine
2017
Completed Phase 3
~2070
Carboplatin
2014
Completed Phase 3
~6670
Docetaxel
1995
Completed Phase 4
~5620
Bevacizumab
2013
Completed Phase 4
~5280
Capecitabine
2013
Completed Phase 3
~3420
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,304 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,868 Previous Clinical Trials
5,051,378 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,770 Previous Clinical Trials
8,061,439 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05007106 — Phase 2
Oral Squamous Cell Carcinoma Research Study Groups: Pembrolizumab/Vibostolimab Co-Formulation, Pembrolizumab, Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort), Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort), Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin, Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel, Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin, Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab, Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin
Oral Squamous Cell Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05007106 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05007106 — Phase 2
Oral Squamous Cell Carcinoma Patient Testimony for trial: Trial Name: NCT05007106 — Phase 2

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’).
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long screening visits will take?
PatientReceived 1 prior treatment
~319 spots leftby Feb 2027