110 Participants Needed

Pembrolizumab Combinations for Small Cell Lung Cancer

Recruiting at 23 trial locations
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Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Merck Sharp & Dohme Corp.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of pembrolizumab and new experimental drugs in patients with advanced lung cancer who did not respond to previous treatments. The goal is to see if this combination is safe and effective. Pembrolizumab helps the immune system attack cancer by blocking a protein that stops immune cells from working. Pembrolizumab has been widely studied and approved for the treatment of various cancers, including lung cancer.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain treatments like systemic anticancer therapy or radiotherapy shortly before starting the study. It's best to discuss your current medications with the study team to get specific guidance.

What safety data exists for pembrolizumab combinations in humans?

The combination of pembrolizumab with other drugs like lenvatinib has been studied in various cancers, showing a safety profile consistent with known effects of each drug. Common side effects include high blood pressure, low thyroid function, diarrhea, nausea, vomiting, loss of appetite, fatigue, and weight loss.12345

What makes the drug combination of pembrolizumab, favezelimab, lenvatinib, MK-4830, and quavonlimab unique for treating small cell lung cancer?

This drug combination is unique because it combines multiple immune checkpoint inhibitors (like pembrolizumab and quavonlimab) with other agents like lenvatinib, which targets blood vessel growth in tumors, potentially enhancing the immune system's ability to fight cancer. This approach is novel for small cell lung cancer, which traditionally has limited treatment options.16789

What data supports the effectiveness of the drug combination of pembrolizumab, lenvatinib, and quavonlimab for small cell lung cancer?

Research shows that pembrolizumab combined with lenvatinib has shown promising results in various solid tumors, including non-small cell lung cancer, with objective response rates (ORR) reaching up to 60% in certain groups. Additionally, the combination of pembrolizumab and quavonlimab has demonstrated encouraging antitumor activity in small cell lung cancer, with ORR ranging from 28% to 40%.16101112

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with Stage IV small cell lung cancer who need second-line therapy after not responding to first treatments including PD-1/PD-L1 inhibitors. They must have a life expectancy over 3 months, measurable disease, and be willing to use contraception. Exclusions include recent major surgery or radiation, active infections, other cancers within 3 years, severe allergies to study drugs, and certain heart or blood vessel problems.

Inclusion Criteria

I have provided a sample of my tumor that has not been treated with radiation.
You are expected to live for more than 3 months.
I am a man and will not have unprotected sex or will use contraception during and for 7 days after my treatment, unless I'm receiving specific immunotherapies.
See 12 more

Exclusion Criteria

Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
I haven't had cancer treatment or experimental drugs in the last 4 weeks.
I have not had a serious wound, ulcer, or bone fracture that hasn't healed in the last 28 days.
See 27 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

Initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents

3 weeks

Efficacy Evaluation

Efficacy evaluation of investigational agents as monotherapy or in combination with pembrolizumab

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 60 months

What Are the Treatments Tested in This Trial?

Interventions

  • Favezelimab
  • Lenvatinib
  • MK-4830
  • Pembrolizumab
  • Quavonlimab
Trial Overview The study tests pembrolizumab combined with investigational agents (quavonlimab/lenvatinib/MK-4830/favezelimab) in two parts: initial safety assessment followed by efficacy evaluation for those with extensive-stage small cell lung cancer resistant to standard treatments. No hypothesis testing; focuses on determining safe dosages and observing effectiveness.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: R-DXdExperimental Treatment1 Intervention
Group II: Coformulation Pembrolizumab/Quavonlimab + MK-4830Experimental Treatment2 Interventions
Group III: Coformulation Pembrolizumab/Quavonlimab + LenvatinibExperimental Treatment2 Interventions
Group IV: Coformulation Pembrolizumab/QuavonlimabExperimental Treatment1 Intervention
Group V: Coformulation Favezelimab/PembrolizumabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

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 profile image

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 profile image

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 profile image

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

Daiichi Sankyo

Industry Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Published Research Related to This Trial

The ongoing KEYNOTE-495/KeyImPaCT study is evaluating the effectiveness of pembrolizumab combined with other therapies in advanced non-small cell lung cancer (NSCLC), with results showing varying objective response rates (ORR) based on tumor characteristics, ranging from 0-12% in low T-cell-inflamed groups to 50-60% in high T-cell-inflamed groups.
The study confirms that assessing T-cell-inflamed gene expression profiles (TcellinfGEP) and tumor mutational burden (TMB) can help identify which patients are more likely to benefit from pembrolizumab-based treatments, while the safety profiles of the combinations remain consistent with previous findings.
Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results.Gutierrez, M., Lam, WS., Hellmann, MD., et al.[2023]
The combination of lenvatinib, a multikinase inhibitor, and pembrolizumab, a PD-1 inhibitor, shows promising antitumor activity and durable responses in various solid tumors, as indicated by preliminary results from the LEAP clinical trial program.
This combination therapy has a manageable safety profile, suggesting it could be a valuable new treatment option for solid cancers that currently have limited therapeutic alternatives.
The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors.Taylor, MH., Schmidt, EV., Dutcus, C., et al.[2021]
In a phase 2 study involving 38 patients with pleural mesothelioma, the combination of pembrolizumab and lenvatinib resulted in a promising objective response rate of 58%, indicating significant anti-tumor activity after prior chemotherapy.
However, the treatment was associated with considerable toxicity, with 26% of patients experiencing serious treatment-related adverse events, including one death, highlighting the need for careful monitoring and supportive care during therapy.
Pembrolizumab plus lenvatinib in second-line and third-line patients with pleural mesothelioma (PEMMELA): a single-arm phase 2 study.Douma, LH., Lalezari, F., van der Noort, V., et al.[2023]

Citations

Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results. [2023]
The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. [2021]
Pembrolizumab plus lenvatinib in second-line and third-line patients with pleural mesothelioma (PEMMELA): a single-arm phase 2 study. [2023]
Phase IB/II Trial of Lenvatinib Plus Pembrolizumab in Patients With Advanced Renal Cell Carcinoma, Endometrial Cancer, and Other Selected Advanced Solid Tumors. [2021]
Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer. [2021]
Optimizing the use of lenvatinib in combination with pembrolizumab in patients with advanced endometrial carcinoma. [2023]
Adverse events and oncologic outcomes with combination lenvatinib and pembrolizumab for the treatment of recurrent endometrial cancer. [2023]
Safety and efficacy of pembrolizumab plus lenvatinib versus pembrolizumab and lenvatinib monotherapies in cancers: A systematic review. [2021]
Characterization and Management of Adverse Reactions From the CLEAR Study in Advanced Renal Cell Carcinoma Treated With Lenvatinib Plus Pembrolizumab. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study. [2021]
Evidence to Date: Evaluating Pembrolizumab in the Treatment of Extensive-Stage Small-Cell Lung Cancer. [2021]
The benefits and risks of pembrolizumab in combination with chemotherapy as first-line therapy in small-cell lung cancer: a single-arm meta-analysis of noncomparative clinical studies and randomized control trials. [2023]
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