RecruitingPhase 1 / Phase 2

A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of new drugs and how well they work, with or without pembrolizumab and/or chemotherapy. It is for people with advanced esophageal squamous cell cancer, a cancer of the food pipe, that has worsened after one prior treatment plan that included platinum chemotherapy and PD-1/PD-L1 immune treatment.

This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests confirm esophageal squamous cell cancer that has spread or cannot be removed with surgery.
  • Your cancer worsened after one standard treatment plan that included platinum chemotherapy and PD-1/PD-L1 drugs, which help the immune system fight cancer.
  • You have provided a stored or recent tumor sample collected during your regular care.
  • Side effects from past cancer treatment are mild or back to your usual level. Hormone problems controlled with replacement hormones and moderate nerve damage may be allowed.

Who can't join

  • Cancer has grown directly into nearby organs, such as the main artery or windpipe, or is active in the brain, spinal cord, or their lining.
  • You lost more than 10% of your body weight in about 2 months before the first study dose.
  • You have a history of severe dry eyes, eyelid or eyelid gland disease, or disease of the eye’s clear front layer that slows healing.
  • You have current or past inflammatory bowel disease, which causes swelling in the gut, or a major risk of gut bleeding. Risks include certain serious wounds, stomach ulcers, or broken bones within 28 days before group assignment, bleeding disorders, inflamed blood vessels, or major gut bleeding within 12 weeks before group assignment.
  • You received an experimental drug or used an experimental device within 4 weeks before study treatment.
  • You have another cancer that is growing or needed treatment in the past 3 years. Some skin cancers and cancers that have not spread beyond their starting layer may be allowed after treatment meant to cure them.
  • You have HIV and a history of Kaposi’s sarcoma or multicentric Castleman disease, or you have received tissue or an organ from a donor.
  • You had significant heart or blood vessel disease within 12 months before the first study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC) * Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy * Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice * Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible Exclusion Criteria: * Direct invasion into adjacent organs such as the aorta or trachea * Has experienced weight loss \>10% over approximately 2 months prior to first dose of study therapy * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Participants with human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * History of allogenic tissue/solid organ transplant * Clinically significant cardiovascular disease within 12 months from first dose of study intervention * Has risk for significant gastrointestinal (GI) bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization

Study sites (5)

AZ

  • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927) · Tucson, AZ 85719Study Coordinator · Study contact · 520-621-2449More trials in Tucson

CA

NY

  • Hematology-Oncology Associates of Central NY, P.C. ( Site 4925) · East Syracuse, NY 13057Study Coordinator · Study contact · 315-472-7504More trials in East Syracuse
  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907) · New York, NY 10032More trials in New York

PA