An Open-Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring (NCT06788509)

To provide continued access to study treatment(s) for those participants currently receiving active study treatment and deriving benefit, and to continue parent study-specified safety monitoring.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Constantine Tam

Key inclusion data

INCLUSION: Be currently participating in the 80948543LYM1001 or 80948543LYM1002 study and receiving JNJ-80948543 or be currently participating in the 87810493LYM1001 study and receiving JNJ-87801493 in combination with JNJ-80948543. Have principal investigator’s assessment that the benefit of continued treatment with JNJ-80948543 outweighs the risks or have principal investigator’s assessment that the benefit of continued treatment with JNJ-80948543 in combination with JNJ-87801493 outweighs the risks. If a participant of childbearing potential is assessed by the investigator as possibly in early pregnancy despite negative pregnancy test, the participant will be excluded from participating in the study and practice at least 1 highly effective method of contraception through 90 days after the last dose of study treatment; if oral contraceptives are used, a barrier method of contraception must also be used. Refer to Appendix 4 of the platform protocol PLATFORMPACAN1001. EXCLUSION: Uses corticosteroids (more than 10 mg daily of prednisone or equivalent) other than for the management of AEs or premedication, in consultation with the sponsor’s medical monitor or designee. An exception is made for prophylaxis for IV contrast allergy. Undergoes radiotherapy, except for palliative radiation given after consultation with the sponsor. Palliative radiotherapy may be used at the sites of disease.