Durvalumab Plus "Booster" RT for Metastatic Adenocarcinoma Pancreas Cancer Post Chemotherapy (GCC 1598)

Conditions

• Metastatic Pancreas Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  Evaluate if the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy
• Radiation Therapy — RADIATION
  The primary intent of RT in this study is to augment a pancreatic cancer-specific immune response when given with durvalumab.

Study Details

Research Hypothesis: The combination of ionizing radiation and immunotherapy (durvalumab) is well tolerated and stimulates a clinically significant pancreas-cancer specific immune response. The primary objective will be to evaluate whether the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy. The primary intent of RT in this study is to augment a pancreatic cancer-specific immune response when given with durvalumab.

Key Dates

Start date

Jul 31, 2017

Status verified

Sep 2019

Primary completion

Dec 31, 2020

Completion

Dec 31, 2022

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Durvalumab + Radiation therapy
  Durvalumab (MEDI4736) 750 mg (or 10mg/kg if the patient weighs \<30 kg) IV Q2W over 1 hour for all patients + Radiation therapy * First lesion to receive 25 Gy / 5 daily consecutive fractions of 5 Gy * Second lesion to receive15 Gy / 5 daily consecutive fractions

Primary Outcome Measure

Improvement in median Progression Free Survival using the combination of RT and durvalumab. [ Time Frame: 6 years ]