Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

NCT03509012 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-01-14

No results posted yet for this study

Summary

This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors

Conditions

  • Carcinoma, Squamous Cell of Head and Neck
  • Carcinoma, Non-Small-Cell Lung
  • Small Cell Lung Carcinoma

Interventions

DRUG

Durvalumab

IV (intravenous)

DRUG

Tremelimumab

IV

DRUG

Cisplatin (dose level 4)

IV

DRUG

Cisplatin (dose level 3)

IV

DRUG

Carboplatin (dose level 1)

IV

DRUG

Carboplatin (dose level 2)

IV

DRUG

Etoposide (dose level 1)

IV

DRUG

Etoposide (dose level 2)

IV

DRUG

Paclitaxel

IV

DRUG

Pemetrexed

IV

RADIATION

External beam radiation (dose level 1)

radiation therapy

RADIATION

External beam radiation (dose level 2)

radiation therapy

RADIATION

External beam radiation (hyperfractionated)

radiation therapy

DRUG

Cisplatin (dose level 1)

IV

DRUG

Cisplatin (dose level 2)

IV

RADIATION

External beam radiation (standard)

radiation therapy

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-02
Primary Completion
2020-12-31
Completion
2025-01-08
FDA Drug
Yes

Countries

  • United States
  • Japan
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT03509012 on ClinicalTrials.gov