Abstract 1155TiP
Background
Nivolumab (NIVO), a programmed death receptor-1 (PD-1)–blocking antibody that releases PD-1 pathway-mediated inhibition of anti-tumor immune responses, is approved for the treatment of multiple cancers. Long-term safety data and collection of overall survival (OS) events could inform the toxicity profile regarding late-onset adverse events (AEs) including immune-related AEs (irAEs) and increase understanding of the impact of underlying disease and comorbidity on long-term survivorship issues in NIVO-treated patients.
Trial design
CheckMate 8TT is a phase II, open-label, pan-tumor, continuation study with a novel rollover design investigating long-term safety of cancer survivors participating in NIVO trials. This study provides an opportunity for uninterrupted NIVO treatment for patients receiving NIVO monotherapy in the parent study, as well as long-term follow-up of those who have completed NIVO therapy. Inclusion criteria include eligibility for NIVO as per parent protocol and patients who are currently within, or have completed, the follow-up phase of the parent study (completed treatment, progressed on treatment, or on subsequent therapy). Exclusion criteria include ineligibility for NIVO as per parent protocol, investigator assessment that continued treatment is not in the best interest of the patient due to lack of clinical benefit from NIVO, AEs, laboratory abnormalities, and/or concomitant illness. There are no exclusion criteria for survival follow-up. For eligible patients, NIVO (480 mg IV every 4 wks or 240 mg IV every 2 wks, as per investigator’s choice) will be continued until progression, unacceptable toxicity, withdrawal of consent, or parent protocol–determined end of treatment. The imaging schedule is per the investigator’s determination and thus mirrors real-world use. The primary objective is evaluation of long-term safety of NIVO in patients on treatment and in follow-up as measured by the incidence of AEs. Long-term efficacy, including OS, from the beginning of treatment in the parent study is an exploratory objective. Additional analyses will potentially include patient demographics, comorbidities, hypersensitivity reactions, and irAE/AE outcomes.
Clinical trial identification
NCT03899155.
Editorial acknowledgement
Katie Groschwitz, PhD, and Matthew Weddig of Spark-Medica, Inc.
Legal entity responsible for the study
Bristol-Myers Squibb.
Funding
Bristol-Myers Squibb.
Disclosure
C. Denlinger: Advisory/Consultancy, Research grant/Funding (institution), Non-remunerated activity/ies: Bristol-Myers Squibb; Advisory/Consultancy: Exelixis; Advisory/Consultancy: Astellas; Advisory/Consultancy: Bayer; Research grant/Funding (institution): Merrimack Pharmaceuticals; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (self), Research grant/Funding (institution): Eli Lilly & Co; Research grant/Funding (institution): Roche/Genentech; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Sanofi Aventis; Research grant/Funding (institution): BeiGene; Honoraria (institution): Lycera; Research grant/Funding (institution): MacroGenics; Research grant/Funding (institution): Agios Pharmaceuticals; Research grant/Funding (institution): Zymeworks; Speaker Bureau/Expert testimony: Taiho. E. Kalinka: Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Merck Sharp & Dohme; Honoraria (self): Roche; Honoraria (self): AstraZeneca. F. Hosein: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. J. Li: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. N. Khushalani: Advisory/Consultancy, Research grant/Funding (institution), Non-remunerated activity/ies: Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Merck; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Huya Biosciences; Research grant/Funding (institution): GlaxoSmithKline; Advisory/Consultancy, Research grant/Funding (institution), Non-remunerated activity/ies: Regeneron; Research grant/Funding (institution): Amgen; Advisory/Consultancy: Array; Advisory/Consultancy: Genentech; Advisory/Consultancy, Non-remunerated activity/ies: Sanofi; Advisory/Consultancy: EMD Serono; Advisory/Consultancy: Jounce; Advisory/Consultancy: Immunocore; Advisory/Consultancy, Data Safety Monitoring Board: AstraZeneca; Advisory/Consultancy, Data Safety Monitoring Board: Incyte; Shareholder/Stockholder/Stock options: Bellicum; Advisory/Consultancy: TransEnterix; Advisory/Consultancy: Amarin; Advisory/Consultancy: Mazor Robotics. All other authors have declared no conflicts of interest.