Study on IL-2, Radiotherapy, and Pembrolizumab for Patients Not Responding to Checkpoint Blockade Therapy
Sponsor: Megan Daly, MD
ClinicalTrials ID:NCT03474497
This clinical trial is testing a new combination of treatments for patients with certain types of cancer that have not responded to previous immunotherapy. The study aims to determine if adding IL-2 and radiotherapy to pembrolizumab can improve treatment outcomes.
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Program Overview
This study is exploring a new treatment approach for patients with metastatic non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), or head and neck squamous cell carcinoma (HNSCC) who have not responded to previous PD-1/PD-L1 checkpoint blockade therapy. The trial will test the safety and effectiveness of combining IL-2 injections, radiotherapy, and pembrolizumab. Patients must have a tumor that can be safely treated with radiotherapy and injections, and another tumor that can be measured for response.
Description
This clinical trial is divided into two phases. In Phase I, researchers will determine the safest dose of IL-2 when combined with radiotherapy and pembrolizumab. In Phase II, they will assess how well this combination works in treating cancer.
Patients will receive pembrolizumab every three weeks, along with IL-2 injections directly into the tumor and radiotherapy. The radiotherapy will be given during the second cycle of treatment, and IL-2 injections will start shortly after the radiotherapy is completed.
Participants will be closely monitored by doctors throughout the study, with regular assessments and imaging tests to track the cancer's response to treatment. The study will continue until the cancer progresses, the treatment is no longer tolerated, or the patient completes 12 months of treatment. After 12 months, patients may continue pembrolizumab as part of standard care.
The main goal is to see if this treatment can help patients who did not respond to previous immunotherapy. Researchers will also monitor the safety and side effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older with metastatic NSCLC, melanoma, RCC, or HNSCC.
- Cancer has not responded to previous PD-1/PD-L1 checkpoint blockade therapy.
- Good overall health with a performance status score of 0 or 1.
- Have a tumor that can be safely treated with radiotherapy and injections.
- Have another tumor that can be measured for response.
- Life expectancy of at least 6 months.
- Adequate organ function based on specific lab tests.
- No other active cancer.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Men must agree to use contraception.
- Signed informed consent and ability to comply with the study protocol.
- No active autoimmune disease or treatment for autoimmune disease.
- Stable thyroid condition if applicable.
Exclusion Criteria
- Uncontrolled medical conditions.
- Participation in another study or use of investigational drugs within 4 weeks.
- Immunodeficiency or use of systemic steroids or immunosuppressive therapy.
- Active tuberculosis.
- Allergy to pembrolizumab.
- Recent use of other cancer treatments or unresolved side effects from previous treatments.
- Other active cancer requiring treatment.
- Active brain metastases or meningitis.
- Active autoimmune disease requiring treatment in the past 2 years.
- Recent use of immunostimulatory or immunosuppressive drugs.
- History of severe lung inflammation or current lung issues.
- Active infection requiring treatment.
- Conditions that may interfere with the study.
- Psychiatric or substance abuse issues affecting participation.
- Pregnant or breastfeeding women.
- History of HIV or active hepatitis B or C.
- Recent live vaccine.
- Unable to tolerate checkpoint inhibitor therapy.
- Severe side effects from previous PD-1/PD-L1 therapy.
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