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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with non-small cell lung cancer or colorectal cancer.
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My body weight is over 30 kg.
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I have at least one cancer lesion that hasn't been treated with radiation.
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My condition has worsened despite previous treatments.
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I am not pregnant or I am post-menopausal.
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I have at least one tumor that can be measured.
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My organs and bone marrow are functioning normally.
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I am mostly active and my doctors expect me to live more than 6 months.
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My tumor is microsatellite stable based on specific tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate
Secondary outcome measures
Incidence of adverse events
Local control rate and abscopal response rates
Objective response per immune-related response (irORR) criteria
+4 moreOther outcome measures
Patient reported symptomatic adverse events(AEs)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C (tremelimumab, durvalumab, and RT)Experimental Treatment3 Interventions
Patients receive tremelimumab and durvalumab and as in Arm A. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.
Group II: Arm B (tremelimumab, Durvalumab, RT)Experimental Treatment3 Interventions
Patients receive tremelimumab and durvalumab and as in Arm A. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.
Group III: Arm A (tremelimumab, durvalumab)Experimental Treatment2 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.
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
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,043 Total Patients Enrolled
Jonathan D SchoenfeldPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with non-small cell lung cancer or colorectal cancer.You are currently taking any other experimental drugs.I haven't had chemotherapy, biologic therapy, or radiotherapy in the last 3 to 6 weeks.My body weight is over 30 kg.I have not received radiation that would harm my healthy tissues.I have been treated with immune therapies but not with anti-PD-1 or anti-PD-L1.I am not pregnant, breastfeeding, and I agree to use effective birth control.I can have a new biopsy for this study.I have at least one cancer lesion that hasn't been treated with radiation.I meet the specific criteria for prior anti-PD-1 or anti-PD-L1 antibody treatment.I have not had major surgery in the last 28 days.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have moderate to severe nerve pain or damage, and will discuss this with the study doctor.I haven't taken immunosuppressive drugs in the last 14 days.I have had cancer before, but it was a different type than my current diagnosis.You have a history of a current, ongoing problem with your immune system.My condition has worsened despite previous treatments.I am not pregnant or I am post-menopausal.I have brain metastases or spinal issues related to cancer that haven't been treated.I have at least one tumor that can be measured.I am eligible for treatments targeting EGFR, ROS1, or ALK as per FDA standards.I still have side effects from previous cancer treatments.You are expected to live for at least 12 more weeks.You have had an organ transplant from another person.My organs and bone marrow are functioning normally.I have no allergies to tremelimumab, MEDI4736, or similar drugs.I am mostly active and my doctors expect me to live more than 6 months.I have had an autoimmune or inflammatory disorder in the last 3 years.My tumor is microsatellite stable based on specific tests.I can understand and am willing to sign the consent form.I have been diagnosed with tuberculosis in the past.I have not received a live vaccine in the last 30 days.I am not currently on any cancer treatments like chemotherapy or hormone therapy.You have HIV.I do not have an active infection, including hepatitis B or C.I don't have lasting side effects from cancer treatment worse than mild.Your heart's electrical activity, called the QT interval, is longer than normal when adjusted for your heart rate.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C (tremelimumab, durvalumab, and RT)
- Group 2: Arm B (tremelimumab, Durvalumab, RT)
- Group 3: Arm A (tremelimumab, durvalumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I sign up for the clinical trial?
"As of 11/8/2022, this trial is no longer looking for new participants. It was originally posted on 6/6/2017. If you are interested in other trials, there are currently 4547 clinical trials recruiting patients with carcinoma and 345 trials for Radiation Therapy that have open enrollment."
Answered by AI
What are the government's thoughts on Radiation Therapy?
"Although there is some evidence of safety, as this trial is only in Phase 2, Power rates the safety of Radiation Therapy at a 2."
Answered by AI
Has anything like this been done before?
"345 medical trials for Radiation Therapy are ongoing in 1325 cities and 58 countries. The first clinical study was completed in 2007 by AstraZeneca. That trial reached Phase 2 of drug approval and enrolled 37 patients. In the years since, another 230 similar studies have concluded."
Answered by AI
What are some of the most common reasons why doctors will recommend radiation therapy to their patients?
"Radiation therapy is most successful in treating stage III non-small cell lung cancer that cannot be removed surgically. Additionally, it can also help those who have not undergone treatment for metastatic ureter urothelial carcinoma and advance directives."
Answered by AI
How many patients are enrolled in this clinical trial?
"Presently, this study is not looking for new participants. The original posting date was June 6th, 2017 and the last update was November 8th, 2022. However, there are 4452 other studies involving carcinoma and 345 trials specifically for radiation therapy that are currently recruiting patients."
Answered by AI
Are there other instances where radiation has been studied to treat patients?
"Out of the 345 ongoing studies on Radiation Therapy, 51 are in Phase 3. The large majority of these trials are based Cordoba, Texas; however, there are 13051 locations globally running these tests."
Answered by AI
In how many different hospitals or research facilities is this study being conducted?
"There are 43 hospitals and medical centers around the country participating in this clinical trial, including Duke University Medical Center in Durham, Smilow Cancer Hospital Care Center-Trumbull in Trumbull, and Vanderbilt University/Ingram Cancer Center in Nashville."
Answered by AI
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