Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Tremelimumab

Antineoplastic Agents, Immunological

Patients will receive 1500 mg durvalumab via IV infusion q4w for up to 4 doses/cycles and 75 mg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 1500 mg durvalumab q4w starting on Week 16. Tremelimumab will be administered first. Durvalumab infusion will start approximately 1 hour after the end of tremelimumab infusion. The duration will be approximately 1 hour for each infusion. Radiotherapy (RT) will be performed using external beam ionizing radiation as standard therapy in accordance with institutional standard practice. RT will be initiated within 7 days after the first of durvalumab and tremelimumab.

Patients will receive 1500 mg durvalumab via IV infusion q4w for up to 4 doses/cycles and 75 mg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 1500 mg durvalumab q4w starting on Week 16. Tremelimumab will be administered first. Durvalumab infusion will start approximately 1 hour after the end of tremelimumab infusion. The duration will be approximately 1 hour for each infusion. The ablation will be performed percutaneously under image guidance as standard therapy at the discretion of the interventional radiologist in accordance with institutional standard practice. Ablation will be performed within 7 days after the first of durvalumab and tremelimumab.

durvalumab

tremelimumab

Radiotherapy (RT) will be performed using external beam ionizing radiation as standard therapy in accordance with institutional standard practice.

Radiotherapy (RT)

Ablation will be performed percutaneously under image guidance as standard therapy at the discretion of the interventional radiologist in accordance with institutional standard practice.

ablation

Neil Segal, MD, PhD

The purpose of this study is to test the safety and effectiveness of two investigational drugs (drugs that are not currently approved by the FDA) given in combination with radiation therapy or ablation.

This will be a Simon two-stage design, phase II study. It will be conducted to determine the efficacy and safety of (1) durvalumab and tremelimumab plus RT in subjects with metastatic CRC who are undergoing RT as standard therapy; and, (2) durvalumab and tremelimumab plus ablation in subjects with metastatic CRC who are undergoing ablation as standard therapy.

A Clinical Trial of Durvalumab and Tremelimumab, Administered With Radiation Therapy or Ablation in Patients With Colorectal Cancer

Phase II Study to Assess the Efficacy of Durvalumab (MEDI4736) and Tremelimumab Plus Radiotherapy or Ablation in Patients With Metastatic Colorectal Cancer

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

MedImmune LLC

AstraZeneca

Memorial Sloan Kettering Cancer Center

No participants were assigned to the Durvalumab and Tremelimumab + ablation arm.

Patients will receive 1500 mg durvalumab via IV infusion q4w for up to 4 doses/cycles and 75 mg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 1500 mg durvalumab q4w starting on Week 16. Tremelimumab will be administered first. Durvalumab infusion will start approximately 1 hour after the end of tremelimumab infusion. The duration will be approximately 1 hour for each infusion.

RT will be initiated within 7 days after the first of durvalumab and tremelimumab.

Durvalumab and Tremelimumab Plus Radiotherapy (RT) or Ablation

Patients will receive 1500 mg durvalumab via IV infusion q4w for up to 4 doses/cycles and 75 mg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 1500 mg durvalumab q4w starting on Week 16. Tremelimumab will be administered first. Durvalumab infusion will start approximately 1 hour after the end of tremelimumab infusion. The duration will be approximately 1 hour for each infusion.

Ablation will be performed within 7 days after the first of durvalumab and tremelimumab.

Durvalumab and Tremelimumab Plus Ablation

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Neil Segal, MD, PhD

Durvalumab and Tremelimumab Plus Radiotherapy (RT)

No participants were enrolled on the Durvalumab and Tremelimumab + ablation arm.

Spots Global Cancer Trial Database for A Clinical Trial of Durvalumab and Tremelimumab, Administered With Radiation Therapy or Ablation in Patients With Colorectal Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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