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

Sponsor
Herlev Hospital
Study ID
NCT02866383
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Biliary Tract Cancer
  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    3 mg/kg is given over 60 minutes I.V. on day 1 just after radiation and then every 2 weeks (q2w)
  • Ipilimumab — DRUG
    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)
  • Radiotherapy — RADIATION
    15 Gy x 1 fraction given on day 1

Study Details

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.

Key Dates

Start date
Nov 30, 2016
Status verified
Sep 2023
Primary completion
Jan 5, 2022
Completion
Nov 30, 2022

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab & Radiotherapy
    Patients will receive nivolumab 3 mg/kg over 60 minutes as an IV infusion on day 1 just after RT and then every 2 weeks (q2w), for a maximum of 52 weeks
  • Experimental: Nivolumab & Ipilimumab & Radiotherapy
    Patients will receive nivolumab 3 mg/kg over 60 minutes as an IV infusion on day 1 just after RT. Thirty minutes after the completion of nivolumab infusion patients will receive ipilimumab 1 mg/kg over 90 minutes IV as an IV infusion. Nivolumab will be given every 2 weeks (q2w) and ipilimumab every 6 weeks (q6w), respectively for a maximum of 52 weeks

Primary Outcome Measure

Clinical benefit rate (CBR) [ Time Frame: 6 months ]

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