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

Phase 1

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-PL

Lead Sponsor: BeiGene, Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

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, and/or tolerate any of the parent study treatments
4. The first dose of study treatment in the LTE study will be received within the treatment interruption period allowed by the parent study. Details for treatment-specific requirements can be found in the relevant appendices,
• The terms treatment interruption and treatment break are not
interchangeable.
Treatment interruption is an unplanned pause in study treatment (eg,
due to adverse event). If the interruption is beyond the period allowed
by the parent study, the acceptability of restarting study treatment will
depend on an agreement between the investigator and the medical
monitor of the LTE study
• Treatment break is a planned stop of study therapy for a patient who
has been treated for significant period of time and derived treatment
benefits. For a patient who is on a treatment break with confirmed CR,
PR, or SD after 2 years of tislelizumab containing treatment, and who
has evidence of PD within 1 year of start of treatment break, the
investigator can consider restarting the study treatment defined in parent study after discussion with the sponsor, contingent on the
continued availability of study medications
5. Female patients of childbearing potential and female partners of
nonsterile males must practice highly effective methods of birth control
initiated before the first dose of study treatment, for the duration of the
study, and after the last dose of study treatment. See Appendix I for
contraception methods. More details on treatment-specific requirements
can be found in the relevant appendices.
6. Male patients are eligible if abstinent or vasectomized or if they agree
to use contraception for the duration of the study, and after the last dose
of study treatment. See Appendix I for contraception methods. More
details on treatment-specific requirements can be found in the relevant
appendices. Nonsterile males receiving investigational drugs or other
genotoxic chemotherapeutic treatment must avoid sperm donation for
the duration of the study and for at least 6 months after the last dose of
study treatment. More details on treatment-specific requirements can be
found in the relevant appendices.
7. A signed informed consent form obtained before enrolling in this LTE
study and receiving study treatment

Specific Inclusion Criteria for Patients Who Continue Survival Follow-up
Only in the LTE Study
1. A signed informed consent form obtained before enrolling in this LTE
study
2. Currently participating in a BeiGene-sponsored eligible parent study in
the survival follow up period.
3. Parent study plans to have survival analysis

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

Patients are not eligible to participate in this study if they meet any of
the following exclusion criteria:
1. Permanently discontinued from all investigational drugs in the parent
study due to unacceptable toxicity, noncompliance with study
procedures, or withdrawal of consent.
2. Have uncontrolled active systemic infection or recent infection
requiring parenteral antimicrobial therapy 14 days before the planned
first dose of treatment in the LTE study
3. Have a life-threatening illness, medical condition, or organ system
dysfunction that, in the investigator's opinion, could compromise the
patient's safety, interfere with the absorption or metabolism of
investigational drugs 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
6. Inability to comply with study procedures
7. Concurrent participation in another therapeutic clinical trial

Specific Exclusion Criteria for Patients Who Continue Survival Follow-up
Only in the LTE Study
There are no specific exclusion criteria for patients who continue
survival follow-up only in the LTE study. Patients in the survival followup
should not be transferred to the LTE if there is no plan for survival
analysis in the parent study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of BeiGene investigational drugs in<br>patients with advanced malignancies.;Secondary Objective: To evaluate the efficacy of BeiGene investigational drugs by following<br>patients for overall survival.;Primary end point(s): Safety as assessed by incidence of all adverse events of special interest, Grade 3, 4, or 5 adverse events, Grade 2 adverse events that affect vital organs (eg, heart, liver), nonserious adverse events that lead to dose modification or drug discontinuation or withdrawal from the trial, and serious adverse events of any severity.;Timepoint(s) of evaluation of this end point: up to 5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival defined as the time from the start of treatment in parent study (or randomization date for a randomized study) until the date of death from any cause.;Timepoint(s) of evaluation of this end point: up to 5 years

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