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Maintenance Ipilimumab + Nivolumab Post Induction Chemotherapy + SBRT for First Line Treatment Stage IV Pancreatic Cancer

NCT05088889 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-28

No results posted yet for this study

Summary

In this study we aim to test the efficacy of a combined and novel approach including induction chemotherapy (per standard of care) followed by SBRT and maintenance ipililumab + nivolumab in the first line setting of stage IV PDAC.

Study Hypothesis:

Cytotoxic chemotherapy followed by hypofractionated radiotherapy will sensitize pancreatic cancer to immunotherapy consisting of combined PD-1 and CTLA4 blockade. We hypothesize that direct targeting of the pancreatic cancer cells by chemotherapy and hypofractionated radiotherapy is necessary for initial anti-tumor response. Furthermore, the combination of immunotherapy as a maintenance strategy will have profound anti-tumor efficacy in this setting.

Implications of hypothesis:

* Improved response rate above historical controls
* Lengthened progression-free survival
* Improved overall-survival

Exploratory Hypothesis:

We hypothesize that baseline markers of immune activation such as Tumor Infiltrating Lymphocytes and CD8+ lymphocytes will correlate with response to ipililumab + nivolumab and that responders will have distinct tumor immune phenotype as determined by immunohistochemistry and gene expression profiling compared to nonresponders.

Conditions

  • Stage IV Pancreatic Cancer

Interventions

DRUG

Nivolumab

Nivolumab administered IV over 30 minutes at a dose of 360mg every 3 weeks

DRUG

ipilimumab

Ipilimumab administered IV over 30 minutes at 1 mg/kg every 6 weeks

RADIATION

Stereotactic body radiation therapy

Three fractions of 8 Gy, treated on alternate days

RADIATION

Low dose irradiation

a single fraction of 2Gy will be given to the metastatic lesions at first progression

Sponsors & Collaborators

Principal Investigators

  • Talia Golan, Prof. · Shaba Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2024-07-01
Completion
2024-07-01

Countries

  • Israel

Study Locations

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Entities

Drugs
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 NCT05088889 on ClinicalTrials.gov