MK-7684A for Advanced Cancers

No longer recruiting at 101 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme Corp.

Must not be taking: Immunosuppressants, Steroids, others

Disqualifiers: Second malignancy, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of drugs, pembrolizumab (also known as KEYTRUDA or MK-3475) and vibostolimab, to determine if they work better together than pembrolizumab alone for certain advanced cancers, including cervical cancer. Researchers aim to discover if this combination can improve response rates and slow cancer growth. People with advanced solid tumors, such as cervical, endometrial, or liver cancer, who haven't received specific treatments before, might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic anticancer therapy, you must stop it at least 4 weeks before joining the trial. Also, if you are on chronic steroid or immunosuppressive therapy, you need to stop it 7 days before starting the study medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of pembrolizumab and vibostolimab has a safety profile similar to each drug used alone. This indicates that using these two drugs together does not cause unexpected side effects beyond those known for each drug individually.

A large review of 31 clinical trials found pembrolizumab alone to be generally safe for various types of cancer. About 74% of patients experienced side effects, but these were mostly expected and manageable by doctors.

The pembrolizumab/vibostolimab combination is currently in the middle phase of testing. This phase usually indicates that earlier studies have shown enough safety to test the treatment in more people. While this is a positive sign, researchers are still learning about its safety when used with other treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the pembrolizumab/vibostolimab co-formulation for advanced cancers because it combines two potent agents in one infusion, potentially enhancing the immune system's ability to fight tumors. Vibostolimab is a novel PD-1 blocker, which, when paired with pembrolizumab, could offer a more comprehensive blockade of immune checkpoints, possibly leading to improved efficacy compared to standard treatments. Additionally, this co-formulation allows patients the flexibility to continue therapy with pembrolizumab alone, tailoring the treatment to individual responses and potentially reducing side effects.

What evidence suggests that this trial's treatments could be effective for advanced cancers?

Studies have shown that pembrolizumab can help treat certain advanced cancers. For instance, when combined with chemotherapy, it helped about 19% of patients with advanced non-small cell lung cancer live for five years. In this trial, participants may receive a combination of pembrolizumab and another drug, vibostolimab. Early studies suggest this combination can delay the progression of advanced cancers by an additional 2.4 months in patients who have already received treatment. Research indicates that using these drugs with other treatments might be more effective against solid tumors. Initial data supports the idea that this combination could be more effective than using pembrolizumab alone in some cases. ^{2 6 7 8 9}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have endometrial cancer.

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

My blood pressure is under control, with or without medication.

Exclusion Criteria

I have both hepatitis B and C.

I have had serious heart problems in the last year.

I have not received a live vaccine within the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab/vibostolimab co-formulation with or without other anticancer therapies, administered via IV infusion every 3 weeks up to 35 cycles

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab
• Pembrolizumab/Vibostolimab Co-Formulation

Trial Overview 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.

How Is the Trial Designed?

Group I: Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab Experimental Treatment 5 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. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Carboplatin/Paclitaxel/Bevacizumab.

Group II: Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel Experimental Treatment 3 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. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Paclitaxel.

Group III: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort) Experimental Treatment 3 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. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib.

Group IV: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort) Experimental Treatment 3 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. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib.

Group V: Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin Experimental Treatment 3 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. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Gemcitabine/Cisplatin

Group VI: Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin Experimental Treatment 3 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. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Capecitabine/Oxaliplatin.

Group VII: Pembrolizumab/Vibostolimab Co-Formulation Experimental Treatment 2 Interventions

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. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy.

Group VIII: Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin Experimental Treatment 4 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. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with 5-Fluorouracil + Cisplatin.

Group IX: Pembrolizumab Experimental Treatment 1 Intervention

Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. merck.com merck.com/news/five-year-data-for-mercks-keytruda-pembrolizumab-plus-chemotherapy-showed-sustained-survival-benefit-versus-chemotherapy-alone-in-two-studies-for-metastatic-non-small-cell-lung-cancer-nsclc/

Five-Year Data for Merck's KEYTRUDA® (pembrolizumab ... Five-year overall survival rate of 19.4% and 18.4% for KEYTRUDA plus chemotherapy in KEYNOTE-189 and KEYNOTE-407, respectively.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38880664/

5-Year Real-World Outcomes With Frontline ... Median OS was 19.2 months (95% CI, 16.6-21.4), and survival rate at 5 years was 25.1% (95% CI, 21.7-28.7). Overall, 266 patients (33 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352578925001468

Real-world outcomes after pembrolizumab treatment for ... Complete response was reached in 25 % of patients in the treatment group (Monk et al.). These studies demonstrated meaningful survival benefits for patients ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01295827

NCT01295827 | Study of Pembrolizumab (MK-3475) in ... The study will investigate the safety, tolerability, and efficacy of pembrolizumab (2 mg/kg and 10 mg/kg) in participants with advanced or metastatic MEL.

5. keytrudahcp.com keytrudahcp.com/efficacy/

Efficacy Data for KEYTRUDA® (pembrolizumab) The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25 ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0959804924000066

Safety profile of pembrolizumab monotherapy based on an ... This pooled analysis of 31 clinical trials showed that pembrolizumab has a consistent safety profile across indications.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5628692/

Safety and efficacy profile of pembrolizumab in solid cancer The results indicated that the overall incidence of any treatment emergent adverse events was 74.3% (95% confidence interval [CI]: 0.671–0.805).

8. merck.com merck.com/news/five-year-survival-data-for-mercks-keytruda-pembrolizumab-in-advanced-non-small-cell-lung-cancer-nsclc-from-first-keynote-trial-at-2019-asco-annual-meeting/

Five-Year Survival Data for Merck's KEYTRUDA® ... KEYTRUDA demonstrated a five-year overall survival (OS) rate of 23.2% in treatment-naïve patients (n=101) and 15.5% in previously treated patients (n=449).

9. keytruda.com keytruda.com/

KEYTRUDA® (pembrolizumab) - Official Site TREATS 18 TYPES OF CANCER, INCLUDING CERTAIN EARLY-STAGE AND ADVANCED CANCERS. ONE OF THOSE CANCERS IS EARLY-STAGE NON—SMALL CELL LUNG CANCER (NSCLC).