Study on Danvatirsen and Durvalumab for Treating Advanced Pancreatic, Lung, and Colorectal Cancers

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02983578

Provider View

This clinical trial is testing a combination of two drugs, danvatirsen and durvalumab, to see if they can help treat advanced pancreatic cancer, non-small cell lung cancer, and colorectal cancer that hasn't responded to other treatments.

Patient Parameters

Program Overview

This study is exploring whether the combination of danvatirsen and durvalumab can effectively treat certain advanced cancers that have spread and are not responding to standard treatments. Danvatirsen may help block proteins that cancer cells need to grow, while durvalumab is an immunotherapy that helps the immune system attack cancer cells. The goal is to see if these drugs together can better control pancreatic, non-small cell lung, and colorectal cancers.

Description

The main goals of this study are to see how well the combination of danvatirsen and durvalumab controls cancer at 4 months and to study certain markers in the tumors that might predict how well the treatment works. Researchers will also look at how the levels of a protein called PD-L1 in the blood relate to treatment results.

Secondary goals include checking for any serious side effects, measuring how long the cancer responds to treatment, and seeing how long patients live without the cancer getting worse.

Patients will receive danvatirsen through an IV on specific days and durvalumab on the first day of each 28-day cycle. The treatment will continue as long as the cancer does not progress and side effects are manageable. After treatment, patients will have follow-up visits to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Have advanced pancreatic, colorectal, or non-small cell lung cancer that hasn't responded to standard treatments.
  • Be in good overall health with a performance status score of 0 or 1.
  • Have at least one measurable tumor.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential and men with partners of childbearing potential must use effective birth control during the study and for 20 weeks after the last dose.
  • Women must not be pregnant or breastfeeding and must have a negative pregnancy test before starting treatment.
  • Must agree to provide a sample of tumor tissue for research purposes.

Exclusion Criteria

  • Have spinal cord compression unless stable and not needing steroids.
  • Have another active cancer, except for certain non-invasive cancers.
  • Have not completed previous cancer treatments before joining the study.
  • Have serious side effects from previous treatments that haven't resolved.
  • Have a history of severe immune-related side effects from prior immunotherapy.
  • Have active autoimmune diseases or inflammatory bowel disease.
  • Have a history of primary immunodeficiency or organ transplant.
  • Have lung disease or a history of severe allergic reactions to study drugs.
  • Have uncontrolled medical conditions or infections, including HIV or hepatitis.
  • Have received a live vaccine within 28 days before starting the study.
  • Have active brain metastases unless stable after treatment.
  • Be pregnant, breastfeeding, or not using effective birth control if of reproductive potential.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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