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STARLET: Niraparib and Dostarlimab for Brain Metastases

This study is testing if a combination of two drugs, niraparib and dostarlimab, can help control advanced cancers that have spread to the brain (brain metastases). You might be able to join if you are 18 or older and have brain metastases from certain advanced cancers, including those with changes in genes like BRCA1/2. The researchers want to see how many people respond to the treatment and how safe it is. They are also looking at specific markers like ATM, BRCA1, and PALB2. The study plans to enroll 120 people, but its current status is unclear.

Study design
This is an interventional study planning to enroll 120 participants. It is a Phase II trial.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05700721

Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~120 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:NiraparibDostarlimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over through study completion; an average of 1 year.

Conditions

Brain Metastases

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NCT05700721

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • M D Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Timothy Yap, MBBS,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Timothy Yap, MBBS,PHD
[email protected]
(713) 563-1784
Email the study team

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Eligibility criteria

Inclusion

Serum total bilirubin ≤1.5xULN OR Direct bilirubin ≤1 x ULN for subjects with total bilirubin levels ≥1.5xULN ) (if associated with liver metastases or Gilbert's disease, ≤2.5 x ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN (if associated with liver metastases, ≤5 x ULN) Coagulation
International Normalized Ratio (INR) or Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) ≤1.5xULN, unless subject is receiving anticoagulant therapy.
Patients who are ≥45 years of age and who have not had menses for \>1 year or have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use an adequate barrier method throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 4.4 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
Refrain from donating sperm plus, either:
Be abstinent from sexual activity as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or
Must agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) 12. Participant must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care. Hence, participants must have the ability to understand and the willingness to sign the approved written informed consent document.

What this trial measures

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0through study completion; an average of 1 year.