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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

BeOne Medicines AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Neoplasms [C04]

Trial duration

23 Feb 2021 → ongoing

Decision date (initial)

2024-03-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

BeiGene, Ltd.

External identifiers

EU CT number

2023-508883-31-00

EudraCT number

2019-002554-23

ClinicalTrials.gov

NCT04164199

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To evaluate the long-term safety of BeiGene investigational drugs in patients with advanced
malignancies

Secondary objectives 1

1. To evaluate the efficacy of BeiGene investigational drugs by following patients for overall survival

Conditions and MedDRA coding

Solid tumors and hamatological malignancies

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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 patient will continue to benefit from and 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
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 L 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 L for contraception methods. Nonsterile males receiving investigational drugs or other genotoxic chemotherapeutic treatment must avoid sperm donation for the duration of the study and after the last dose of study treatment. More details on treatmentspecific 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

Exclusion criteria 8

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
8. Are participating in the follow-up phase in a parent study for which there is no planned survival analysis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Safety as assessed by incidence of all AEs of special interest, Grade 3, 4, or 5 AEs, Grade 2 AEs that affect vital organs (eg, heart, liver, brain, lung, kidney), nonserious AEs that lead to dose modification or drug discontinuation or withdrawal from the trial, and SAEs of any severity.

Secondary endpoints 1

1. Overall survival defined as the time from start of treatment in parent study (or randomization date for a randomized study) until the date of death from any cause.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

BeOne Medicines AG

Sponsor organisation

BeOne Medicines AG

Address

Aeschengraben 27

City

Basel

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medical Officer

Public contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medical Officer

Third parties 3

Locations

3 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications