OCIPERLIMAB for Solid tumors|Haematological malignancies

Inclusion criteria

• {"criterion_text":"- Currently participating in a BeiGene-sponsored eligible parent study\n- Fulfills treatment criteria specified in the parent study protocol\n- In the opinion of the investigator, the patient will continue to benefit from and tolerate any of the parent study treatments\n- 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\n- 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.\n- 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 treatment-specific requirements can be found in the relevant appendices.\n- A signed informed consent form obtained before enrolling in this LTE study and receiving study treatment"}

Exclusion criteria

• {"criterion_text":"- Permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent.\n- 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\n- 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\n- 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\n- Pregnant or lactating women\n- Inability to comply with study procedures\n- Concurrent participation in another therapeutic clinical trial\n- Are participating in the follow-up phase in a parent study for which there is no planned survival analysis"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assessment of safety by incidence counts of AEs of special interest; grading of AEs (Grade 2, 3, 4, 5); recording non-serious AEs leading to dose modification or discontinuation; and recording SAEs of any severity."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time-to-event measurement: time from start of treatment in the parent study (or randomization date for randomized studies) to date of death from any cause; overall survival follow-up."}

Italy

Latest Decision Or Authorization Date

11-03-2024

Number Of Sites

4

Number Of Participants

7

France

Latest Decision Or Authorization Date

11-06-2025

Number Of Sites

6

Number Of Participants

13

Poland

Latest Decision Or Authorization Date

20-01-2026

Number Of Sites

2

Number Of Participants

1

Primary sponsor

Full Name

BeOne Medicines AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

IQVIA Limited

Responsibilities

sponsorDuties code 12; contact eu_clinical_trials_information@iqvia.com

Name

PPD (UK) Limited

Responsibilities

sponsorDuties code 8; contact emeaasiasafetycentral.sm@ppd.com

Name

Scout Clinical

Responsibilities

sponsorDuties code 15; Patient reimbursement (Poland and France only); contact clientcompliance@meetingprotocol.com

Third parties

• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties code 12","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties code 15; Patient reimbursement (Poland and France only)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United Kingdom","full_name":"PPD (UK) Limited","duties_or_roles":"sponsorDuties code 8","organisation_type":"Pharmaceutical company"}