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

Phase 1

Active, not recruiting

• Conditions: solid tumors and hematological malignancies; MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002554-23-IT
• Lead Sponsor: BeiGene Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-21
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 243

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
4. The first dose of study treatment in the extension study will be received within the treatment interruption period allowed by the parent study:
a. For tislelizumab monotherapy or in combination with chemotherapies, interruption period is no more than 12 weeks
b. For pamiparib monotherapy, interruption period is no more than 21 consecutive days due to toxicities other than anemia and no more than 56 consecutive days for investigational drug-related anemia
c. For pamiparib in combination with tislelizumab, interruption period is no more than 21 consecutive days for pamiparib and no more than 42 consecutive days for tislelizumab
d. 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 extension study

Specific Inclusion Criteria for Participants Who Continue Survival Followup
Only in the Extension Study:
1. Signed informed consent obtained prior to enrolling in this long-term extension study
2. Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion following tislelizumab-containing therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 61
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 182

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
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 extension study
5. Pregnant or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified