430 Participants Needed

Tislelizumab + Pamiparib for Cancer

Recruiting at 170 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems that you may continue with treatments from the parent study, but it's best to discuss your specific situation with the study team.

What data supports the effectiveness of the drug combination of Tislelizumab and Pamiparib for cancer?

Research shows that combining pamiparib, a drug that helps repair damaged DNA, with tislelizumab, a drug that helps the immune system fight cancer, has shown antitumor activity in patients with advanced solid tumors. Additionally, similar drugs like atezolizumab have been effective in treating certain types of breast cancer, suggesting potential benefits of this combination.12345

Is the combination of Tislelizumab and Pamiparib safe for humans?

Studies have shown that the combination of Tislelizumab and Pamiparib has been tested for safety in patients with advanced solid tumors. The research indicates that this combination is generally safe, but like all treatments, it may have side effects, which were monitored during the trials.12567

What makes the drug combination of pamiparib and tislelizumab unique for treating advanced solid tumors?

The combination of pamiparib, a PARP inhibitor that helps repair damaged DNA in cancer cells, and tislelizumab, an immune checkpoint inhibitor that helps the immune system attack cancer cells, is unique because it targets both the cancer cells' DNA repair mechanisms and the immune system's ability to recognize and destroy cancer cells, offering a novel approach for treating advanced solid tumors.12348

What is the purpose of this trial?

This is an open-label, multicenter, extension study to evaluate the long-term safety and efficacy of BeiGene investigational drugs in participants with advanced malignancies who participated in a prior BeiGene-sponsored clinical study (parent study).

Research Team

SD

Study Director

Principal Investigator

BeiGene

Eligibility Criteria

This trial is for patients with advanced malignancies who were previously in a BeiGene study and may benefit from continued treatment. It's not for those who had severe side effects, recent serious infections, or used other cancer treatments between studies. Pregnant women and individuals with life-threatening conditions are also excluded.

Inclusion Criteria

The doctor believes that you will still benefit from taking tislelizumab and pamiparib either alone or together.
I am allowed to take pamiparib for my solid tumor, except for GBM, if my doctor agrees.
Currently participating in a BeiGene-sponsored eligible parent study
See 1 more

Exclusion Criteria

I do not have an uncontrolled infection or one that needed IV drugs before the study.
I stopped tislelizumab or pamiparib treatment due to severe side effects, not following study procedures, or withdrawing consent.
I don't have any health issues that could risk my safety in the study.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tislelizumab, Pamiparib, and other investigational agents as part of the extension study

up to 7 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 7 years

Treatment Details

Interventions

  • Pamiparib
  • Tislelizumab
Trial Overview The study tests long-term safety of Tislelizumab and/or Pamiparib alone or combined with other agents like Capecitabine, Temozolomide, etc., in participants with advanced cancers to see if they continue to help without causing new issues.
Participant Groups
18Treatment groups
Experimental Treatment
Group I: R - Tislelizumab and Surzebiclimab and LBL-007 Combination TherapyExperimental Treatment3 Interventions
Group II: Q - Tislelizumab and LBL-007 Combination TherapyExperimental Treatment2 Interventions
Group III: P - Tislelizumab and Zanidatamab Combination TherapyExperimental Treatment2 Interventions
Group IV: O - Tislelizumab and Lenvatinib Combination TherapyExperimental Treatment2 Interventions
Group V: N - Tislelizumab and BGB-15025 Combination TherapyExperimental Treatment2 Interventions
Group VI: M - Tislelizumab and Surzebiclimab Combination TherapyExperimental Treatment2 Interventions
Group VII: L - Tislelizumab and BGB-A445 Combination TherapyExperimental Treatment2 Interventions
Group VIII: K - Tislelizumab and Fruquintinib Combination TherapyExperimental Treatment2 Interventions
Group IX: J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 MonotherapyExperimental Treatment2 Interventions
Group X: I - Tislelizumab and Ociperlimab Combination TherapyExperimental Treatment2 Interventions
Group XI: H - Tislelizumab and Sitravatinib Combination TherapyExperimental Treatment2 Interventions
Group XII: G - Tislelizumab and Pamiparib Combination TherapyExperimental Treatment2 Interventions
Group XIII: F - Pamiparib and Temozolomide Combination TherapyExperimental Treatment2 Interventions
Group XIV: E - Zanidatamab MonotherapyExperimental Treatment1 Intervention
Group XV: D - BGB-15025 MonotherapyExperimental Treatment1 Intervention
Group XVI: C - Sitravatinib MonotherapyExperimental Treatment1 Intervention
Group XVII: B - Pamiparib MonotherapyExperimental Treatment1 Intervention
Group XVIII: A - Tislelizumab MonotherapyExperimental Treatment1 Intervention

Pamiparib is already approved in China for the following indications:

🇨🇳
Approved in China as Pamiparib for:
  • Ovarian cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials
216
Recruited
32,500+

Findings from Research

In a study involving 180 patients with advanced solid tumors, the combination of pamiparib and tislelizumab demonstrated an overall objective response rate (ORR) of 20%, with the highest response (47.4%) observed in patients with triple-negative breast cancer (TNBC) who had BRCA1/2 mutations or homologous recombination deficiency.
While the treatment showed promising antitumor activity, it was associated with a significant incidence of treatment-emergent adverse events, with 61.7% of patients experiencing grade 3 or higher side effects, indicating that while the therapy is effective, careful monitoring for safety is necessary.
Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-expansion stage of a multicentre, open-label, phase I trial.Friedlander, M., Mileshkin, L., Lombard, J., et al.[2023]
The combination of pamiparib (a PARP inhibitor) and tislelizumab (an anti-PD-1 antibody) was generally well tolerated in a study of 49 patients with advanced solid tumors, with a recommended phase 2 dose established as tislelizumab 200 mg every 3 weeks plus pamiparib 40 mg twice daily.
Out of the participants, 20% achieved an objective response, including two complete responses, indicating that this combination therapy may provide clinical benefits and warrants further investigation.
Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial.Friedlander, M., Meniawy, T., Markman, B., et al.[2020]
In a phase 3 trial involving 332 patients with advanced nonsquamous non-small cell lung cancer (nsq-NSCLC), the combination of tislelizumab and chemotherapy significantly improved progression-free survival (PFS) compared to chemotherapy alone, with a median PFS of 9.7 months versus 7.6 months.
The addition of tislelizumab also resulted in higher response rates and longer duration of response, making it a promising first-line treatment option for patients with advanced nsq-NSCLC.
Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial.Lu, S., Wang, J., Yu, Y., et al.[2021]

References

Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-expansion stage of a multicentre, open-label, phase I trial. [2023]
Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial. [2020]
Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial. [2021]
Atezolizumab (in Combination with Nab-Paclitaxel): A Review in Advanced Triple-Negative Breast Cancer. [2020]
Pamiparib in patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutations: a phase II study. [2023]
AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. [2023]
Efficacy and safety of tislelizumab for malignant solid tumor: a systematic review and meta-analysis of phase III randomized trials. [2023]
Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis. [2023]
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