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Immune Checkpoint Inhibition in Combination With Radiation Therapy in Pancreatic Cancer or Biliary Tract Cancer Patients

NCT02866383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-09-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nivolumab

3 mg/kg is given over 60 minutes I.V. on day 1 just after radiation and then every 2 weeks (q2w)

DRUG

Ipilimumab

1 mg/kg is given over 90 minutes I.V. on day 1 30 minutes after the completion of nivolumab infusion and then every 6 weeks IV (q6w)

RADIATION

Radiotherapy

15 Gy x 1 fraction given on day 1

Sponsors & Collaborators

Principal Investigators

  • Inna Chen, MD · Herlev and Gentofte Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2022-01-05
Completion
2022-11-30

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02866383 on ClinicalTrials.gov