120 Participants Needed

Niraparib + Dostarlimab for Brain Cancer

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Overseen ByTimothy Yap, MBBS,PHD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

To learn if the combination of niraparib and dostarlimab can help to control advanced cancer that has spread to the brain.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not be receiving other interventional anticancer treatments at the same time. It's best to discuss your specific medications with the trial team.

How is the drug combination of Niraparib and Dostarlimab unique for brain cancer treatment?

The combination of Niraparib and Dostarlimab is unique because it targets cancer cells by exploiting their DNA repair weaknesses and enhancing the immune system's ability to fight cancer. Niraparib, a PARP inhibitor, increases DNA damage in cancer cells, while Dostarlimab, an immune checkpoint inhibitor, helps the immune system recognize and attack these damaged cells, offering a novel approach compared to traditional treatments.12345

What data supports the effectiveness of the drug combination Niraparib and Dostarlimab for brain cancer?

Dostarlimab has been approved for treating certain types of endometrial cancer, showing it can be effective against some cancers. Niraparib has been studied for advanced breast cancer with specific genetic mutations, indicating it may help in treating cancers with similar characteristics.23467

Who Is on the Research Team?

Timothy Yap | MD Anderson Cancer Center

Timothy Yap

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults (18+) with advanced cancers that have spread to the brain, including specific types such as BRCA1/2m cancer and various lung and breast cancers. Participants must have had previous treatment, possess measurable brain metastasis not requiring immediate intervention or steroids, and adequate organ function. They cannot be pregnant or breastfeeding and must agree to contraception.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.
My organs are functioning well.
I have a brain tumor that can be measured.
See 9 more

Exclusion Criteria

I cannot swallow pills or have a gut condition affecting medication absorption.
Participants with an inactive, known or suspected autoimmune disease
Participants unable to undergo contrast enhanced brain MRI
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive niraparib and dostarlimab to assess intracranial objective response rate and systemic antitumor activity

12 weeks

Follow-up

Participants are monitored for safety, tolerability, and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dostarlimab
  • Niraparib
Trial Overview The trial is testing a combination of two drugs: Niraparib, a PARP inhibitor, and Dostarlimab, a PD-1 inhibitor. The goal is to see if these drugs can control advanced cancer in patients whose disease has progressed into the brain.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: MonotherapyExperimental Treatment2 Interventions

Dostarlimab is already approved in European Union, United States for the following indications:

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Approved in European Union as Jemperli for:
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Approved in United States as Jemperli for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Published Research Related to This Trial

In a phase II trial involving 65 patients with recurrent glioblastoma, the pan-PI3K inhibitor buparlisib showed minimal efficacy as a single agent, with only 8% of patients achieving 6-month progression-free survival.
Despite demonstrating significant brain penetration and some reduction in PI3K pathway activity in tumor tissue, the incomplete blockade of the pathway likely contributed to the lack of clinical effectiveness, suggesting that more effective PI3K inhibitors may be needed.
Buparlisib in Patients With Recurrent Glioblastoma Harboring Phosphatidylinositol 3-Kinase Pathway Activation: An Open-Label, Multicenter, Multi-Arm, Phase II Trial.Wen, PY., Touat, M., Alexander, BM., et al.[2020]
Dostarlimab-gxly (Jemperli) has received accelerated approval from the FDA for treating adults with mismatch repair deficient recurrent or advanced endometrial cancer and solid tumors, indicating its potential effectiveness in these specific cancer types.
This approval highlights the importance of targeted therapies in oncology, particularly for patients with specific genetic markers that may influence treatment outcomes.
New Drug for Mismatch Repair Deficient Endometrial Cancer and Solid Tumors.Aschenbrenner, DS.[2023]
In a phase II trial involving 17 patients with melanoma brain metastasis (MBM) who had previously undergone multiple treatments, buparlisib, a PI3K inhibitor, was well tolerated but did not result in any intracranial responses, with only three patients achieving stable disease.
The median progression-free survival was 42 days and median overall survival was 5 months, suggesting limited efficacy in this heavily pretreated population, highlighting the need for further exploration of combination therapies targeting the PI3K-AKT pathway.
An open-label, single-arm, phase II trial of buparlisib in patients with melanoma brain metastases not eligible for surgery or radiosurgery-the BUMPER study.Amaral, T., Niessner, H., Sinnberg, T., et al.[2022]

Citations

Buparlisib in Patients With Recurrent Glioblastoma Harboring Phosphatidylinositol 3-Kinase Pathway Activation: An Open-Label, Multicenter, Multi-Arm, Phase II Trial. [2020]
New Drug for Mismatch Repair Deficient Endometrial Cancer and Solid Tumors. [2023]
An open-label, single-arm, phase II trial of buparlisib in patients with melanoma brain metastases not eligible for surgery or radiosurgery-the BUMPER study. [2022]
Dostarlimab: First Approval. [2021]
Niraparib for Advanced Breast Cancer with Germline BRCA1 and BRCA2 Mutations: the EORTC 1307-BCG/BIG5-13/TESARO PR-30-50-10-C BRAVO Study. [2023]
IOLite: phase 1b trial of doublet/triplet combinations of dostarlimab with niraparib, carboplatin-paclitaxel, with or without bevacizumab in patients with advanced cancer. [2022]
A Prospective Phase II Single-arm Study of Niraparib Plus Dostarlimab in Patients With Advanced Non-small-cell Lung Cancer and/or Malignant Pleural Mesothelioma, Positive for PD-L1 Expression and Germline or Somatic Mutations in the DNA Repair Genes: Rationale and Study Design. [2021]
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