Immunotherapy + Radiation for Colorectal and Lung Cancer

Recruiting at45 trial locations

Overseen by Jonathan D Schoenfeld

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies the side effects of durvalumab and tremelimumab and to see how well they work with or without high or low-dose radiation therapy in treating patients with colorectal or non-small cell lung cancer that has spread to other parts of the body (metastatic). Immunotherapy with durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving durvalumab and tremelimumab with radiation therapy may work better in treating patients with colorectal or non-small cell lung cancer.

Research Team

Jonathan D Schoenfeld

Principal Investigator

Dana-Farber - Harvard Cancer Center LAO

Eligibility Criteria

This trial is for adults with metastatic colorectal or non-small cell lung cancer who've had disease progression after prior therapy. They must have measurable disease, be in good physical condition (ECOG <=1), not pregnant, and willing to use birth control. Exclusions include recent chemotherapy, known allergies to trial drugs, uncontrolled illnesses, HIV-positive status, and certain previous treatments.

Inclusion Criteria

I have been diagnosed with non-small cell lung cancer or colorectal cancer.

My body weight is over 30 kg.

I can have a new biopsy for this study.

Exclusion Criteria

You are currently taking any other experimental drugs.

I haven't had chemotherapy, biologic therapy, or radiotherapy in the last 3 to 6 weeks.

I have not received radiation that would harm my healthy tissues.

Treatment Details

Interventions

• Durvalumab (Checkpoint Inhibitor)
• Radiation Therapy (Radiation)
• Tremelimumab (Checkpoint Inhibitor)

Trial Overview The study tests the effectiveness of durvalumab and tremelimumab immunotherapies with or without radiation therapy on metastatic cancers. It's a phase II randomized trial where patients are assigned by chance to receive either high/low-dose radiation combined with the drugs or the drugs alone.

Participant Groups

Group I: Cohort 2, Arm B (tremelimumab, durvalumab, LD-RT) Experimental Treatment 3 Interventions

Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.

Group II: Cohort 2, Arm A (tremelimumab, durvalumab, HD-RT) Experimental Treatment 3 Interventions

Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.

Group III: Cohort 1, Arm C (tremelimumab, durvalumab) Experimental Treatment 2 Interventions

Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.

Group IV: Cohort 1, Arm B (tremelimumab, Durvalumab, LD-RT) Experimental Treatment 3 Interventions

Patients receive tremelimumab and durvalumab and as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.

Group V: Cohort 1, Arm A (tremelimumab, durvalumab, HD-RT) Experimental Treatment 3 Interventions

Patients receive tremelimumab and durvalumab and as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.

Durvalumab is already approved in Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School