Phase II Study of Niraparib and Dostarlimab for Advanced Cancers with Brain Metastases (STARLET)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05700721

Provider View

This clinical trial is exploring whether a combination of two drugs, niraparib and dostarlimab, can help control advanced cancers that have spread to the brain.

Patient Parameters

Program Overview

The purpose of this study is to find out if using the drugs niraparib and dostarlimab together can effectively treat advanced cancers that have spread to the brain. Researchers are looking at how well the treatment works in shrinking brain tumors, how long the effects last, and the overall safety of the treatment. They are also studying how the drugs affect the immune system and other medications, and are collecting samples to understand more about the cancer and treatment response.

Description

The main goal of this study is to see how well the combination of niraparib and dostarlimab works in treating brain metastases from advanced cancers. Researchers will measure how much the brain tumors shrink and how long the response lasts. They will also evaluate the overall safety and effectiveness of the treatment, including how it affects the body and other medications the patient may be taking.

In addition to the main objectives, the study will explore how the drugs interact with the immune system and other biological markers. Researchers will collect samples of cerebrospinal fluid (CSF) and blood to study the effects of the treatment and to look for signs of how well the treatment is working or if there is resistance.

Participants will need to meet certain health criteria and provide tissue samples for testing. The study will also monitor the use of other medications, such as steroids and pain relievers, and assess any changes in seizure activity.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have brain metastases and one of the following advanced cancers: BRCA1/2 mutated cancer, HRR-aberrant non-BRCA1/2 cancer, small cell lung cancer, non-small cell lung cancer, or triple negative breast cancer.
  • Have specific genetic changes in certain HRR genes, as determined by the study team.
  • Any previous brain surgery or radiation must have been done at least one week before starting the study.
  • Have had at least one prior treatment for their cancer.
  • Have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Have adequate organ function based on blood tests.
  • Have at least one measurable brain tumor that meets specific criteria.
  • Provide a tumor tissue sample for testing.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 180 days after the last dose.
  • Men must agree to use contraception and not donate sperm during the study and for 180 days after the last dose.
  • Agree not to breastfeed during the study and for 180 days after the last dose.
  • Sign an informed consent form and be willing to comply with study requirements.

Exclusion Criteria

  • Cannot be receiving other cancer treatments at the same time.
  • Cannot have conditions that prevent MRI scans or MRI contrast use.
  • Cannot have untreated or symptomatic spinal cord compression.
  • Cannot have leptomeningeal disease.
  • Cannot have previously received both a PARP inhibitor and a PD-1/L1 inhibitor together.
  • Cannot have had major surgery within 3 weeks before starting the study.
  • Cannot have received cancer treatment within 2 weeks before starting the study.
  • Cannot have a known allergy to the study drugs.
  • Cannot have certain autoimmune diseases or interstitial lung disease.
  • Cannot have a second cancer unless treated and cancer-free for 2 years.
  • Cannot have active hepatitis B or C, unless treated and under control.
  • Cannot have uncontrolled high blood pressure.
  • Cannot have a history of MDS or AML.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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