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Monoclonal Antibodies

MK-7684A for Advanced Cancers

Phase 2
Waitlist Available
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
Must not have
Concurrent active hepatitis B and hepatitis C virus infection
Active infection requiring systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5.5 years
Awards & highlights

Summary

This trial is testing a new treatment that combines two medications to see if it works better than the current treatment for serious cancers, particularly cervical cancer. One of the medications has shown promising results in treating various cancers, including cervical cancer. The goal is to find out if this combination can improve patient outcomes by helping the immune system fight cancer more effectively.

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.
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.
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 cancer is advanced and cannot be surgically removed.
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My cervical cancer is one of the following types: squamous, adenosquamous, or adenocarcinoma.
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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 have been diagnosed with head and neck squamous cell carcinoma.
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My cancer can be measured using standard imaging tests.
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My cancer in the bile ducts or gallbladder cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have both hepatitis B and C.
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I am currently on medication for an infection.
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I have had a transplant of an organ or tissue from another person.
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I have been treated for an autoimmune disease in the last 2 years.
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I have previously been treated with specific immune therapy drugs.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 local standard of care (SOC) 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 up to 45 cycles
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) up to 45 cycles.
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 3
~2850
Cisplatin
2013
Completed Phase 3
~3120
Gemcitabine
2017
Completed Phase 3
~1920
Carboplatin
2014
Completed Phase 3
~6120
Bevacizumab
2013
Completed Phase 4
~5540
Oxaliplatin
2011
Completed Phase 4
~2890
Lenvatinib
2017
Completed Phase 4
~2040
5-Fluorouracil
2012
Completed Phase 3
~7800
Paclitaxel
2011
Completed Phase 4
~5810
Docetaxel
1995
Completed Phase 4
~6550
Capecitabine
2013
Completed Phase 3
~3970

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Oral Squamous Cell Carcinoma (OSCC) include immune checkpoint inhibitors like Pembrolizumab (a PD-1 inhibitor) and investigational agents such as Vibostolimab (an anti-TIGIT antibody). These treatments work by blocking proteins that cancer cells use to evade the immune system. PD-1 inhibitors prevent the PD-1 receptor on T-cells from interacting with its ligands, thereby enhancing T-cell activity against cancer cells. Anti-TIGIT antibodies inhibit the TIGIT pathway, further boosting T-cell responses. This dual approach is significant for OSCC patients as it enhances the immune system's ability to target and destroy cancer cells, potentially improving treatment efficacy and reducing side effects compared to conventional therapies.
Novel immune-modulating drugs for advanced head and neck cancer.Toxic epidermal necrolysis associated with nivolumab treatment for head and neck cancer.The promise of immunotherapy in head and neck squamous cell carcinoma.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,735 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,966 Previous Clinical Trials
5,176,063 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,849 Previous Clinical Trials
8,080,270 Total Patients Enrolled

Media Library

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