What side effects are associated with this type of intervention?

Common treatments for Oral Squamous Cell Carcinoma, such as pembrolizumab (a PD-1 inhibitor), can cause side effects including fatigue, rash, pruritus, diarrhea, and hypothyroidism. Severe immune-related adverse events like pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis may also occur. When combined with chemotherapy, additional side effects like nausea, vomiting, and myelosuppression are more frequent.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), including oral squamous cell carcinoma (OSCC). This approval is based on its efficacy in improving overall survival, either alone or in combination with chemotherapy. Nivolumab, another PD-1 inhibitor, has also received FDA approval for similar indications. These treatments are part of a class of immune checkpoint inhibitors that have shown significant promise in treating OSCC.

What other types of research exist?

Promising alternatives to Pembrolizumab/Vibostolimab co-formulation for Oral Squamous Cell Carcinoma patients include: 1) Nivolumab, which has demonstrated improved overall survival in recurrent/metastatic HNSCC patients in the CheckMate 141 trial. 2) Budigalimab, a novel anti-PD-1 monoclonal antibody, which has shown efficacy in HNSCC patients in phase 1 studies. 3) Durvalumab, another immune checkpoint inhibitor, which has shown potential in patients with high PD-L1 expression in HNSCC. These alternatives offer different mechanisms of action and have shown promising results in clinical trials.

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Monoclonal Antibodies

MK-7684A for Advanced Cancers

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

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

Select...

I have endometrial cancer.

Select...

I agree to follow the study's rules for using birth control.

Select...

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 cancer is in the esophagus or where my stomach meets my esophagus.

Select...

I have been diagnosed with liver cancer (HCC).

Select...

I have been diagnosed with head and neck squamous cell carcinoma.

Select...

My cancer can be measured using standard imaging tests.

Select...

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:

Select...

I have both hepatitis B and C.

Select...

I am currently on medication for an infection.

Select...

I have had a transplant of an organ or tissue from another person.

Select...

I have been treated for an autoimmune disease in the last 2 years.

Select...

I have previously been treated with specific immune therapy drugs.

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

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

Awards & Highlights

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 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

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

~3150

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

~2070

5-Fluorouracil

2012

Completed Phase 3

~7800

Paclitaxel

2011

Completed Phase 4

~5450

Docetaxel

1995

Completed Phase 4

~6550

Capecitabine

2013

Completed Phase 3

~4280

0 / 14Eligibility criteria met

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.