To hear about similar clinical trials, please enter your email below

Trial Title: A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors

NCT ID: NCT05491317

Condition: Non-CNS Tumor

Conditions: Official terms:
Pembrolizumab

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Intervention model description: Part 1 is sequential, Part 2 is parallel (randomized)

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: GEN1042
Description: Intravenous
Arm group label: Radiotherapy + GEN1042
Arm group label: Radiotherapy + GEN1042 + Pembrolizumab

Intervention type: Drug
Intervention name: Pembrolizumab
Description: Intravenous
Arm group label: Radiotherapy + GEN1042 + Pembrolizumab

Intervention type: Radiation
Intervention name: Radiotherapy
Description: Radiotherapy
Arm group label: Radiotherapy + GEN1042
Arm group label: Radiotherapy + GEN1042 + Pembrolizumab

Summary: The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.

Detailed description: The study will be conducted in two parts: Part 1 (dose-finding) and Part 2 (randomization). Part 1 will evaluate the safety of immunoradiotherapy combinations and establish the dose(s) to be evaluated in Part 2. Part 2 will evaluate the anti-tumor activity of immunoradiotherapy combinations at the established dose(s) from Part 1. Participants in both parts are treated with one of the following combinations: - Radiotherapy + GEN1042 - Radiotherapy + GEN1042 + Pembrolizumab While participants in Part 1 are assigned sequentially (GEN1042 without pembrolizumab is investigated first), participants in Part 2 are randomized 1:1 in the two treatment arms.

Criteria for eligibility:
Criteria:
Key Inclusion Criteria: - Participants with histologically confirmed non-central nervous system (CNS) solid tumor that is metastatic and for whom there is no available standard therapy. - At least 18 years of age. - Signed informed consent prior to any screening procedures. - Measurable disease according to RECIST v1.1. - Life expectancy of >3 months. - Qualify for palliative radiotherapy as an available option for disease management. - Eastern Cooperative Oncology Group (ECOG) 0-1. - Normal or adequate liver, renal, cardiac and bone marrow function. Key Exclusion Criteria: - Prior malignancy except for non-melanoma skin cancers and in situ cancers. - Condition contraindicating radiotherapy. - Rapidly progressing disease. - Active, known or suspected autoimmune disease. - History of non-infectious pneumonitis that required steroids or currently has pneumonitis. - Contraindications to the use of pembrolizumab. - Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment. - Received an allogeneic tissue/solid organ transplant. - Active infection requiring systemic therapy. Note: Other protocol defined inclusion and exclusion criteria may apply.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Institut Bergonie

Address:
City: Bordeaux
Zip: 33076
Country: France

Status: Recruiting

Facility:
Name: Oscar Lambret Center

Address:
City: Lille
Zip: 59000
Country: France

Status: Withdrawn

Facility:
Name: Centre Leon Berard

Address:
City: Lyon
Zip: 69008
Country: France

Status: Recruiting

Facility:
Name: Institut Gustave Roussy

Address:
City: Villejuif
Zip: 94805
Country: France

Status: Recruiting

Start date: March 8, 2023

Completion date: July 2026

Lead sponsor:
Agency: Genmab
Agency class: Industry

Collaborator:
Agency: BioNTech SE
Agency class: Industry

Source: Genmab

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05491317

Login to your account

Did you forget your password?