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New treatment option for Esophageal Squamous Cell Carcinoma
Official title 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)
ClinicalTrials.gov ID: NCT05319730
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main inclusion and
You likely can't join if
- 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...
- 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...
- Direct invasion into adjacent organs such as the aorta or trachea
See the full eligibility criteria
- The main inclusion and
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Los Angeles, California, United States
- East Syracuse, New York, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Natal, Rio Grande do Norte, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, Brazil
- Santiago, Region M. de Santiago, Chile
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Xinxiang, Henan, China
- Zhengzhou, Henan, China
- Huai'an, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Frankfurt am Main, Hesse, Germany
- Düsseldorf, North Rhine-Westphalia, Germany
- Dresden, Saxony, Germany
+ 30 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Los Angeles, California, United States; East Syracuse, New York, United States; New York, New York, United States; Pittsburgh, Pennsylvania, United States; Natal, Rio Grande do Norte, Brazil and 44 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.