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New treatment option for Brain Metastases
Official title Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)
ClinicalTrials.gov ID: NCT05700721
What this study is testing
What is Niraparib?
Niraparib is an investigational medicine, being studied as a potential treatment for brain metastases.
Also referred to as MK-4827.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if the combination of niraparib and dostarlimab can help to control advanced cancer that has spread to the brain.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Age ≥ 18 years old. 2. Participant must have brain metastasis and either 1\. Advanced BRCA1/2m cancer 2. Advanced HRR-aberrant, non-BRCA1/2m...
- Platelets ≥ 100,000 / mcL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤1.5xULN OR Measured or calculated creatinine clearance ≥50 mL/min for participants. Hepatic
- Serum total bilirubin ≤1.5xULN OR Direct bilirubin ≤1 x ULN for people with total bilirubin levels ≥1.5xULN ) (if associated with liver metastases or...
You likely can't join if
- Participant must not be simultaneously receiving treatment anticancer treatment.
- Participant must not have contraindications to MRI (implanted metal device or foreign bodies) or MRI contrast (insufficient renal function or...
- A history of / or suffers from claustrophobia or subject feels unable to lie flat and still on their back for the required period of time in an MRI...
- Participant must not have symptomatic or untreated spinal cord compression.
- Participant must not have evidence of leptomeningeal disease.
- Participant must not have previously received a combination of PARP inhibitor and PD-1/L1inhibitor. Participant must not have previously received...
See the full eligibility criteria
Who can join
- 1\. Age ≥ 18 years old. 2. Participant must have brain metastasis and either 1\. Advanced BRCA1/2m cancer 2. Advanced HRR-aberrant, non-BRCA1/2m cancer 3. Advanced small cell lung cancer 4. Advanced non-small cell lung...
- Platelets ≥ 100,000 / mcL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤1.5xULN OR Measured or calculated creatinine clearance ≥50 mL/min for participants. Hepatic
- Serum total bilirubin ≤1.5xULN OR Direct bilirubin ≤1 x ULN for people 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. 8\. Participant must have at least one...
- 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...
- 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...
- Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment. 11\. Male participants are eligible to participate if they agree to the following during the 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...
What rules you out
- Participant must not be simultaneously receiving treatment anticancer treatment.
- Participant must not have contraindications to MRI (implanted metal device or foreign bodies) or MRI contrast (insufficient renal function or allergy).
- A history of / or suffers from claustrophobia or subject feels unable to lie flat and still on their back for the required period of time in an MRI or PET/CT scanner.
- Participant must not have symptomatic or untreated spinal cord compression.
- Participant must not have evidence of leptomeningeal disease.
- Participant must not have previously received a combination of PARP inhibitor and PD-1/L1inhibitor. Participant must not have previously received equivalent of full dose single agent PARPi. Prior therapy with...
- For participants choosing optional CSF collection via lumbar puncture: no medical contraindication to lumbar puncture may be present (including severe coagulopathy, radiographic concern for impending herniation or...
- Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
- Participant must not have received systemic anticancer therapy ≤2 weeks prior to initiating protocol therapy.
- Previous systemic radiation therapy encompassing \>20% of the bone marrow (but not encompassing the CNS) within 2 weeks
- Previous stereotactic or highly conformal radiotherapy within 1 week before the start of dosing for this study, whole brain radiotherapy within 2 weeks.
- Participant must not have a known hypersensitivity to niraparib and dostarlimab components or excipients.
- Participants with an inactive, known or suspected autoimmune disease. people with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia)...
- Participant must not have a history of interstitial lung disease.
- Participants with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.
- Participant has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- Patients with prostate cancer are excluded from this trial.
- Participant has a known history of active hepatitis B or hepatitis C. Prior treated hepatitis B or C with undetectable viral load may be enrolled.
- Participants who have a known history of HIV positive and are on effective anti-retroviral therapy with documented undetectable viral load and CD4 count ≥350 within 6 months of the first dose of study treatment are...
- Participants unable to undergo contrast enhanced brain MRI.
- Participants unable to swallow pills or have significant gastrointestinal disease which would preclude the adequate oral absorption of medications.
- Patients who have received live vaccines within 30 days of study entrance.
- Patients with uncontrolled high blood pressure (HTN \>140/90).
- Patients with prior diagnosis of MDS or AML.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.