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A Trial of Durvalumab and Tremelimumab in Combination With SBRT in Patients With Metastatic Cancer

NCT03212469 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-05-08

No results posted yet for this study

Summary

The study is an open label, multicentric, Phase I/II trial aiming to evaluate the safety, the clinical activity and abscopal anti-tumor effects of a therapeutic strategy associating Durvalumab in conjunction with SBRT or Durvalumab + Tremelimumab in conjunction with SBRT in patients with metastatic squamous cell carcinoma of head and neck, lung, or esophagus.

Conditions

Interventions

DRUG

Durvalumab

Preliminary steps : Safety Runs Safety run of the dual combination Durvalumab as single agent at the selected dose of 1500mg, every 4 weeks (Q4W) from C1D1 up to 13 doses Safety run of the triple combination: Durvalumab at 1500mg every 4 weeks (Q4W) from C1D1 up to 13 doses, Efficacy step * Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with * SBRT at C1D15, then * Durvalumab Q4W alone for up to 9 additional doses

DRUG

Tremelimumab

Preliminary steps : Safety Runs Safety run of the triple combination: Tremelimumab at 75mg/Q4W for up to 4 doses Efficacy step * Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with * SBRT at C1D15, then * Durvalumab Q4W alone for up to 9 additional doses

RADIATION

SBRT

Preliminary steps : Safety Runs Safety run of the dual combination: SBRT at C1D15. Safety run of the triple combination: SBRT at C1D15. Efficacy step * Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with * SBRT at C1D15, then * Durvalumab Q4W alone for up to 9 additional doses

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Eric DEUTSCH, MD, PhD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2025-02-24
Completion
2025-02-24

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03212469 on ClinicalTrials.gov