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Monoclonal Antibodies

Pembrolizumab/Vibostolimab + Docetaxel for Non-Small Cell Lung Cancer

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

Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days prior to randomization

Has PD as determined by the investigator after platinum doublet chemotherapy for metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 21 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving two drugs, pembrolizumab and vibostolimab, given together or separately. The trial will compare these drugs to a placebo (fake drug) plus a standard cancer drug, docetaxel. The trial is testing whether the new treatment is better than the standard treatment at slowing or stopping cancer growth.

Who is the study for?

This trial is for adults with metastatic non-small cell lung cancer (NSCLC) who have seen their disease progress after platinum chemotherapy and anti-PD-1/PD-L1 therapy. They must be in good physical condition, not pregnant or breastfeeding, willing to use contraception, and have no severe allergies to the drugs being tested or significant health issues like active infections or autoimmune diseases.Check my eligibility

What is being tested?

The study tests a combination of pembrolizumab/vibostolimab with docetaxel against docetaxel alone in patients whose NSCLC has worsened despite previous treatments. The goal is to see if adding pembrolizumab/vibostolimab can improve survival without the cancer getting worse compared to just using docetaxel.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting various organs, infusion-related reactions from the drug entering your body, fatigue, blood disorders that may affect how your blood clots or fights infection, and potential harm to an unborn baby if pregnancy occurs during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer progressed after platinum-based chemotherapy for metastatic disease.

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My lung cancer diagnosis is confirmed and it has spread.

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I have at least one tumor that can be measured on a CT or MRI scan.

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I have given a sample of my tumor for PD-L1 testing.

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My cancer is not suitable for EGFR, ALK, or ROS1 targeted therapy.

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My cancer has worsened despite treatment with a PD-1/PD-L1 inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment

Secondary outcome measures

Duration of Response (DOR) Per RECIST 1.1 by BICR Assessment

Number of Participants Who Discontinued Study Treatment Due to an AE

Number of Participants Who Experienced an Adverse Event (AE)

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2: Pembrolizumab/Vibostolimab coformulationExperimental Treatment1 Intervention

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle will be 21 days.

Group II: Arm 1: Pembrolizumab/Vibostolimab coformulation + DocetaxelExperimental Treatment2 Interventions

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m^2 via IV infusion Q3W. Each cycle will be 21 days.

Group III: Arm 3: Placebo + DocetaxelActive Control2 Interventions

Participants receive normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m^2 IV infusion Q3W. Each cycle will be 21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~5620

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,567 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,316 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,225 Total Patients Enrolled

Media Library

Pembrolizumab/Vibostolimab coformuation (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04725188 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Arm 2: Pembrolizumab/Vibostolimab coformulation, Arm 3: Placebo + Docetaxel, Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel

Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab/Vibostolimab coformuation Highlights & Side Effects. Trial Name: NCT04725188 — Phase 2

Pembrolizumab/Vibostolimab coformuation (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04725188 — 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 coformulation received FDA approval?

"Pembrolizumab/Vibostolimab coformulation is currently in Phase 2 of clinical trials. This indicates that, while there is some data supporting its safety, none yet exists to vouch for its efficacy. Therefore, our team has given it a score of 2."

Answered by AI

Are we currently looking for people to participate in this experiment?

"Unfortunately, this particular clinical trial is no longer recruiting patients. The study was first posted on April 20th, 2021 and received its last update June 30th, 2022. However, there are still many other trials actively searching for participants that might be a match. For example, there are currently 2036 trials actively searching for participants with carcinoma, non-small-cell lung and 1306 trials for Pembrolizumab/Vibostolimab coformuation actively recruiting patients"

Answered by AI

What is the precedent for using this Pembrolizumab/Vibostolimab drug combination?

"Pembrolizumab/Vibostolimab coformuation is being trialed in 1306 different clinical studies, 243 of which are Phase 3 trials. The large number of locations (55567) conducting these trials suggests that this treatment is under significant investigation."

Answered by AI

What are Pembrolizumab/Vibostolimab coformuation's most popular applications?

"The pembrolizumab/vibostolimab coformulation is used to treat various cancers, including unresectable melanoma, microsatellite instability high, and sarcoma."

Answered by AI

How many patients are being given this opportunity to participate in this research?

"This trial is no longer enrolling patients. The listing was created on April 20th, 2021 and last updated on June 30th, 2022. For those still searching for ongoing trials, there are presently 2036 clinical trials actively enrolling patients with carcinoma, non-small-cell lung and 1306 studies for Pembrolizumab/Vibostolimab coformuation actively recruiting participants."

Answered by AI

Could you inform me as to how many hospitals are included in this research project?

"Currently, this clinical trial is enrolling patients at 10 sites. The locations of the centres are in Saint Louis, Springfield and Bronx as well other cities. If you wish to enroll, consider selecting a site that is close to reduce travel time requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)

2021. "Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04725188.

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