Spots Global Cancer Trial Database for Immune Checkpoint Inhibition in Combination With Radiation Therapy in Pancreatic Cancer or Biliary Tract Cancer Patients

Study Description

Brief Summary: This is a prospective, randomized, open-label phase 2 study in patients with metastatic PC or BTC refractory or intolerant to at least one line of prior systemic chemotherapy with gemcitabine or platinum-containing regimens to determine the efficacy and safety of nivolumab or nivolumab plus ipilimumab administered concurrently with high dose RT. Patients with metastatic PC or BTC who are feasible candidates for radiation and biopsy of primary and/or metastatic lesions will be included.

Detailed Description: This was a randomized phase II trial conducted at Herlev \& Gentofte Hospital. Patients were stratified according to PS and randomized into two arms (1:1) (Appendix Figure A1 and Data Supplement, online only). Patients received SBRT consisting of 15 Gy (day 1) to a single primary or metastatic lesion with 3 mg/kg of intravenous nivolumab (IV) on day 1 and every 2 weeks (q2w) (Arm A), or SBRT consisting of 15 Gy (day 1) with 3 mg/kg of IV nivolumab (day 1) q2w and 1 mg/kg of IV ipilimumab on day 1 and every 6 weeks (Arm B). A safety phase involving a run-in assessment of three patients from each arm (n = 6) was followed by the expansion phase. The patients were monitored for dose-limiting toxicities prior to the expansion. Treatment was continued for a maximum of 52 weeks or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or clear clinical deterioration according to the investigator's judgment.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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