Evaluating new treatments for advanced esophageal cancer after prior PD-1 therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 multicenter, randomized, open-label study aims to assess the safety and efficacy of investigational agents, with or without pembrolizumab and/or chemotherapy, in patients with advanced esophageal squamous cell carcinoma (ESCC) who have previously received PD-1/PD-L1 treatment. Participants must have documented disease progression after one line of standard therapy that included a platinum agent. The study will analyze the effects of various treatment combinations on this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)
  Tucson, Arizona, United States Recruiting
• UCLA Hematology/Oncology - Santa Monica ( Site 4905)
  Los Angeles, California, United States Recruiting
• Hematology-Oncology Associates of Central NY, P.C. ( Site 4925)
  East Syracuse, New York, United States Recruiting
• UPMC Hillman Cancer Center-UPMC ( Site 4904)
  Pittsburgh, Pennsylvania, United States Recruiting
• Liga Norte Riograndense Contra o Câncer ( Site 4303)
  Natal, Rio Grande do Norte, Brazil Recruiting
• Hospital Nossa Senhora da Conceição ( Site 4301)
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting

+8 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combination therapies for esophageal squamous cell carcinoma (KEYMAKER-U06 Substudy 06E)

  This trial will test pembrolizumab together with an investigational antibody-drug conjugate (I-DXd), with or without chemotherapy, as a first-line treatment for people with locally advanced unresectable or metastatic esophageal squamous cell carcinoma.

  Recruiting at 52 sites Phase 1/2 Merck Sharp & Dohme LLC · Pittsburgh, Pennsylvania and 51 other locations · NCT06780111

• Investigating ALE.P02 for treating specific solid tumors in adults

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  Recruiting at 39 sites Phase 1/2 Alentis Therapeutics AG · Scottsdale, Arizona and 40 other locations · NCT06747585

• Neoadjuvant therapy for resectable esophageal squamous cell carcinoma

  This study is testing if a new combination of treatments can help people with operable esophageal cancer do better than the usual chemotherapy before surgery.

  Recruiting at 3 sites Phase 2 Tang-Du Hospital · Xi'an, Shaanxi and 2 other locations · NCT06006650

• Combining pembrolizumab with chemotherapy for esophageal cancer treatment

  This study is testing if combining a drug called pembrolizumab with chemotherapy can help people with advanced esophageal cancer live longer and have better outcomes before surgery compared to standard treatment.

  Recruiting Phase 3 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT04807673

• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

  This study tests whether adding SBRT to standard lenvatinib plus pembrolizumab helps people with metastatic kidney cancer who have stable disease after initial treatment.

  Recruiting at 8 sites Phase 2 Kidney Cancer Research Bureau · Kazan' and 7 other locations · NCT07928167

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.