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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