OncoMatch/Clinical Trials/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)

Is NCT05700721 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Niraparib and Dostarlimab for brain metastases.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT05700721Data as of May 2026

Treatment: Niraparib · Dostarlimab — To learn if the combination of niraparib and dostarlimab can help to control advanced cancer that has spread to the brain.

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Extracted eligibility criteria

Biomarker criteria

Required: BRCA1 pathogenic mutation

Advanced BRCA1/2m cancer

Required: BRCA2 pathogenic mutation

Advanced BRCA1/2m cancer

Required: ATM aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: BRIP1 aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: CDK12 aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: CHEK1 aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: CHEK2 aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: FANCL aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: PALB2 aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: RAD51 aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: RAD51B aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: RAD51C aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: RAD51D aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: RAD52 aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Required: RAD54L aberration

actionable aberrations in one or more of the following HRR genes: BRCA1/2, ATM; BRIP1; CDK12; CHEK1; CHEK2; FANCL; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD52; RAD54L, or other related genes

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Cannot have received: PARP inhibitor and PD-1/PD-L1 inhibitor combination

Participant must not have previously received a combination of PARP inhibitor and PD-1/L1inhibitor.

Cannot have received: PARP inhibitor

Exception: equivalent of full dose single agent PARPi

Participant must not have previously received equivalent of full dose single agent PARPi.

Lab requirements

Blood counts

ANC ≥1,500 /mcL; Platelets ≥ 100,000 / mcL; Hemoglobin ≥ 9.0 g/dL

Kidney function

Serum creatinine ≤1.5xULN OR Measured or calculated creatinine clearance ≥50 mL/min

Liver function

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); AST and ALT ≤2.5 x ULN (if associated with liver metastases, ≤5 x ULN)

Adequate organ function as described below: ... CBC test should be obtained without transfusion or receipt of colony-stimulating factors in the 2 weeks before obtaining.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

M D Anderson Cancer Center · Houston, Texas

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