← Back to Search

Checkpoint Inhibitor

Immunotherapy + Radiation for Colorectal and Lung Cancer

Phase 2

Waitlist Available

Led By Jonathan D Schoenfeld

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed non-small cell lung cancer (cohort 1) or colorectal cancer (cohort 2)

Body weight > 30 kg

Must not have

Receipt of prior radiotherapy or condition for any reason that would contribute radiation dose that would exceed tolerance of normal tissues

Pregnant women, breastfeeding women, or male or female patients of reproductive potential who are not willing to employ effective birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects of two immunotherapies, durvalumab and tremelimumab, in combination with high or low-dose radiation therapy, in treating patients with metastatic colorectal or non-small cell lung cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune system reactions that can affect organs, fatigue, infusion-related reactions similar to allergic responses during drug administration, potential harm to an unborn child necessitating contraception requirements for participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My body weight is over 30 kg.

Select...

I have at least one cancer lesion that hasn't been treated with radiation.

Select...

My condition has worsened despite previous treatments.

Select...

I am not pregnant or I am post-menopausal.

Select...

I have at least one tumor that can be measured.

Select...

My organs and bone marrow are functioning normally.

Select...

I am mostly active and my doctors expect me to live more than 6 months.

Select...

My tumor is microsatellite stable based on specific tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I am not pregnant, breastfeeding, and I agree to use effective birth control.

Select...

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Select...

I have had cancer before, but it was a different type than my current diagnosis.

Select...

I have brain metastases or spinal issues related to cancer that haven't been treated.

Select...

I am eligible for treatments targeting EGFR, ROS1, or ALK as per FDA standards.

Select...

I have no allergies to tremelimumab, MEDI4736, or similar drugs.

Select...

I have been diagnosed with tuberculosis in the past.

Select...

I am not currently on any cancer treatments like chemotherapy or hormone therapy.

Select...

I do not have an active infection, including hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Incidence of Grade 3-5 Adverse Events

Local Control Rate and Abscopal Response Rate

Objective Response Per Immune-related Response (irRC) Criteria

+3 more

Other study objectives

Patient reported symptomatic adverse events(AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 2, Arm B (tremelimumab, durvalumab, LD-RT)Experimental Treatment3 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 Treatment3 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 Treatment2 Interventions

Group IV: Cohort 1, Arm B (tremelimumab, Durvalumab, LD-RT)Experimental Treatment3 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 Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Durvalumab

2017

Completed Phase 2

~3750