Trials / Active Not Recruiting

Active Not RecruitingNCT04522336

Pembrolizumab and Chemoradiotherapy for the Treatment of Unresectable Gastroesophageal Cancer

A Pilot Trial of Pembrolizumab Plus Chemoradiotherapy in Participants With Unresectable Gastroesophageal Cancer

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 16 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase I trial investigates how well pembrolizumab and chemoradiotherapy works in treating patients with gastroesophageal cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as fluorouracil, oxaliplatin and docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Giving pembrolizumab together with chemoradiotherapy may help to control gastroesophageal cancer.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the clinical activity (as assessed by complete clinical response rate) of pembrolizumab plus chemoradiation. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of pembrolizumab plus chemoradiation. II. To determine the overall survival efficacy of pembrolizumab plus chemoradiation. III. Evaluate progression free survival (PFS) by local investigator review and by blinded central radiologists' review. EXPLORATORY OBJECTIVES: I. To explore the association between PD-L1 expression by immunohistochemistry, somatic gene expression profiling, and clinical efficacy of pembrolizumab. II. To explore the relationship between genomic variation and response to study treatment. III. To identify molecular (genomic, metabolic, and/or proteomic) biomarkers that may correlate with clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of pembrolizumab in combination with chemoradiation. IV. To determine the effect of pembrolizumab plus chemoradiation treatment on tumor T cell infiltration. OUTLINE: INDUCTION CHEMOTHERAPY: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment with pembrolizumab repeats every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive oxaliplatin IV over 2 hours on day 1 followed by fluorouracil IV over 48 hours once every 2 weeks (Q2W) for 8 weeks (4 cycles) in the absence of disease progression or unacceptable toxicity. CONSOLIDATION CHEMORADIATION: After a 3 week treatment free period, patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive fluorouracil IV continuous over 5 days (Monday through Friday) for 5 weeks and docetaxel IV over 1 hour once a week (QW) for 5 weeks in the absence of disease progression or unacceptable toxicity. Starting no later than 3 days after the beginning of the Consolidation Chemoradiation period, patients also undergo 28 fractions of radiation therapy in the absence of disease progression or unacceptable toxicity. After a 6-9 week treatment free period, patients continue pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 3 weeks for up to 30 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, then every 9-12 weeks thereafter.

Conditions

Interventions

Type	Name	Description
DRUG	Docetaxel	Given IV
DRUG	Fluorouracil	Given IV
DRUG	Oxaliplatin	Given IV
BIOLOGICAL	Pembrolizumab	Given IV
RADIATION	Radiation Therapy	Receive radiation therapy

Timeline

Start date: 2020-09-16
Primary completion: 2027-07-18
Completion: 2027-07-18
First posted: 2020-08-21
Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04522336. Inclusion in this directory is not an endorsement.