Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer

Conditions

• Metastatic Colorectal Carcinoma
• Metastatic Lung Non-Small Cell Carcinoma
• Stage IV Colorectal Cancer AJCC v7
• Stage IV Lung Non-Small Cell Cancer AJCC v7
• Stage IVA Colorectal Cancer AJCC v7
• Stage IVB Colorectal Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — BIOLOGICAL
  Given IV
• Radiation Therapy — RADIATION
  Undergo radiation therapy
• Tremelimumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Aug 14, 2017

Status verified

Jan 2026

Primary completion

Dec 31, 2023

Completion

Jan 2, 2027

Study Design

Enrollment

110 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1, Arm A (tremelimumab, durvalumab, HD-RT)
  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.
• Experimental: Cohort 1, Arm B (tremelimumab, Durvalumab, LD-RT)
  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.
• Experimental: Cohort 1, Arm C (tremelimumab, durvalumab)
  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.
• Experimental: Cohort 2, Arm A (tremelimumab, durvalumab, HD-RT)
  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.
• Experimental: Cohort 2, Arm B (tremelimumab, durvalumab, LD-RT)
  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.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to 2 years ]

Locations (41)

Find similar trials in Phoenix, AZ

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