Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone & in Combination with Nivolumab in Advanced Solid Tumors

Completed

• Conditions: advanced solid tumour, advanced stage cutaneous melanoma and Lung/NSCLC (adenocarcinoma and squamous cell carcinoma). Other tumor histologies may also be included by the Sponsor.; Solid Tumors

• Registration Number: NL-OMON54185
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1) Participants must be at least 18 years old and have histologic or cytologic
confirmation of
a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with
measurable
disease per RECIST v1.1 or per PCWG 3 criteria for prostate and have at least
one soft-tissue lesion accessible for biopsy.
b) Eastern Cooperative Oncology Group Performance Status of 0 or 1
c) The Safety Evaluation of Combination Doses of BMS-986218 with Nivolumab
(Part 1B):
i) Select solid tumor histologies will be permitted during dose escalation,
except for
participants with CNS metastases as the only site of active disease. The
included
histologies will be NSCLC (squamous or adenocarcinoma), gastric adenocarcinoma
(including GE junction), TNBC, CRC (adenocarcinoma), pancreatic adenocarcinoma,
metastatic castrate resistant prostate adenocarcinoma, urothelial carcinoma or
SCCHN (oral cavity, pharyngeal, oropharyngeal, hypopharynx, or laryngeal tumors
only). Any other cancers of the
head and neck, including salivary gland and neuroendocrine tumors, are excluded
from
enrollment. Histologically confirmed recurrent or metastatic carcinoma of the
nasopharynx, SCC or other cancers of the skin of head and neck, and
non-squamous histologies are not allowed. Additional tumor histologies may also
be included by the Sponsor.
ii) Participants must have received, and then progressed, relapsed, or been
intolerant to at
least 2 systemic therapy regimens with proven survival benefit in the advanced
or
metastatic setting according to tumor type, where available. If the participant
refuses
or is not eligible for these regimens, the reason must be documented in the
medical record. However, if anti-PD-1 therapy is approved in a given
indication, participants
are eligible to receive this treatment as part of the combination regimen in
this study
prior to having completed 2 prior systemic therapy regimens after discussion and
agreement with the Medical Monitor (or designee). For hormone-sensitive
cancers, all
previously received and available hormonal therapies will be considered as 1
systemic
therapy regimen for the purposes of eligibility. For prostate cancer, only
metastatic
castrate resistant prostate cancer is allowed.
d) The Randomized BMS-986218 Monotherapy Cohort Expansion in Cutaneous Melanoma
(Part 2A):
i) Participants with advanced stage cutaneous melanoma who have received
standard therapies with proven survival benefit including prior immunotherapy
with an anti-PD-1 or anti-PD-L1 containing regimen and must have progressive or
recurrent disease after prior PD-1/PD-L1 directed therapy. Participants must
not have received prior anti-CTLA-4 therapy in the advanced or metastatic
setting. Additionally, participants with cutaneous melanoma must have also been
offered mutation-directed therapy, if indicated, that has proven survival
benefit; if a participant refuses such
therapy, it must be documented in the medical record. No more than 1
intervening therapy is allowed but not required between prior
anti-PD-1/anti-PD-L1 containing regimen and BMS-986218. No more than 70% of the
randomized participants should have had progression of disease within a period
of 6 months of start of therapy with anti-PD-1/PD-L1 agent. Only cutaneous
melanoma is allowed. Mucosal an

Exclusion Criteria

Participants with primary CNS malignancies, or tumors with CNS metastases as
the only site of disease, will be excluded. Participants with controlled brain
metastases; however, will be allowed to enroll. Controlled brain metastases are
defined as no radiographic progression for at least 4 weeks following radiation
and/or surgical treatment (or 4 weeks of observation if no intervention is
clinically indicated), and no longer taking steroids for at least 2 weeks prior
to first dose of study treatment, and with no new or progressive neurological
signs and symptoms.

Study & Design

• Study Type: Interventional
• Study Design: Not specified