Study of Tislelizumab and/or Pamiparib Containing Treatments in Participants With Advanced Malignancies

• Status: Enrolling by invitation
• Trial end date: 2021-12-16
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter, extension study to evaluate the long-term safety of tislelizumab or pamiparib given either as monotherapy or in combination with each other or with other agents in participants with advanced malignancies who participated in a prior BeiGene sponsored clinical study (parent study).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Capecitabine; Pemetrexed; Temozolomide

Criteria

Key Inclusion Criteria:

1. Currently participating in a BeiGene-sponsored eligible parent study

2. Fulfills treatment criteria specified in the parent study protocol

3. In the opinion of the investigator, the participant will continue to benefit from tislelizumab and/or pamiparib treatment as monotherapy or in combination.

Note: For patients with GBM, continuation on single agent pamiparib or single agent temozolomide will not be permitted.

Note: For patients with solid tumors (other than GBM), receiving single agent pamiparib is allowed if deemed clinically appropriate by the investigator. Continued treatment with single agent temozolomide will not be permitted.

4. The first dose of study treatment in the LTE study will be received within the treatment interruption period allowed by the parent study:

1. For tislelizumab monotherapy or in combination with chemotherapies, the interruption period is no more than 12 weeks

2. For pamiparib monotherapy, interruption period is no more than 21 consecutive days due to toxicities other than anaemia and no more than 56 consecutive days for investigational drug-related anaemia

3. For pamiparib in combination with tislelizumab, the interruption period is no more than 21 consecutive days for pamiparib and no more than 42 consecutive days for tislelizumab

4. For pamiparib in combination with low dose temozolomide, the interruption period is no more than 28 consecutive days due to toxicities other than anaemia and no more than 56 consecutive days for investigational drug-related anaemia

5. If the interruption period is beyond the period allowed by the parent study, the acceptable length of interruption will depend on an agreement between the investigator and the medical monitor of the LTE study

Specific Inclusion Criteria for Participants Who Continue Survival Follow-up Only in the Extension Study:

1. Signed informed consent obtained prior to enrolling in this LTE study

2. Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion following tislelizumab-containing therapy

Key Exclusion Criteria:

1. Permanently discontinued from either tislelizumab and/or pamiparib treatment in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent. Participants who were treated with pamiparib or tislelizumab in combination with other agents and are still receiving pamiparib or tislelizumab but have discontinued the other agent(s) are eligible with the exception of patients with GBM receiving the combination of pamiparib and low-dose temozolomide

2. Have uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy prior to the start of the extension study

3. Have a life-threatening illness, medical condition, or organ system dysfunction that in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of tislelizumab or pamiparib, or put the study outcomes at undue risk

4. Underwent treatment with any systemic anticancer treatment (other than treatment permitted in the parent study) during the time between the last treatment in the parent study and the first dose of study treatment in the LTE study

5. Pregnant or lactating women

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.