Status:
WITHDRAWN
Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Oncovir, Inc.
Conditions:
Stage IV NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Veterans with advanced lung cancer may benefit from recent advances in technologies that is designed to change the activities of their own white blood cells and help kill tumors. However, many cancers...
Detailed Description
This is a phase 1b, a first-in-humans, study to examine the safety and feasibility of administration of intratumor (IT) IVIG + poly-ICLC (Hiltonoll®), and intramuscular (IM) poly-ICLC (Hiltonoll®) for...
Eligibility Criteria
Inclusion
- Veterans with advanced (stage IV) NSCLC
- Eligible to receive ICI/antiPD-1mAb
- No known mutation actionable for first line treatment
- An Eastern Cooperative Oncology Group (ECOG) performance-status (PS) score of 2 or less (ECOG PS is a 5-point scale in which higher scores reflect greater disability)
- Veterans' responses will be defined as eligible to enroll in HAITEN-ICIs if they meet all criteria
- To minimize the effects of immunosuppression on the ability to induce antitumor immunity, the investigators will recruit those who have not received systemic cytotoxic chemotherapy (e.g., platinum, taxane, pemetrexed, etc.), do not have major immunosuppression, and are not recipients of organ transplantation
- Based on our patient population at the MEDVAMC, the investigators estimate that \~30-40% of participants would be receiving systemic chemotherapy and ICIs concurrently, and \~60-70% will be receiving ICI monotherapy
- Therefore, the investigators anticipate no difficulty in meeting the recruitment goal of 16 persons at our center over two years and \~18 at each of the other sites over the 4-year study period
Exclusion
- Veterans with
- Concurrent other malignancies, except for localized prostate or localized skin cancer
- Uncontrolled rheumatologic diseases (such as rheumatoid arthritis)
- Current usage of biologics or immunosuppressive therapies
- Status post organ transplant
- An acute respiratory illness (pneumonia, bronchitis, upper respiratory tract infection) in the preceding 4 weeks
Key Trial Info
Start Date :
June 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06064279
Start Date
June 4 2024
End Date
June 4 2024
Last Update
September 19 2024
Active Locations (1)
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1
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211