A Phase 1/2a Study of BMS-986179 Administered in Combination with Nivolumab (BMS-936558) in Subjects with Advanced Solid Tumors
- Conditions
- all solid tumors in part 1 and only NSCLC, RCC, CRPC, SCCHN, melanoma and pancreatic cancer in part 2.advanced solid tumorscancer
- Registration Number
- NL-OMON47607
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Signed informed consent including consent for submission of a fresh tumor
sample (and if available archival).
At least 18 years old and have histological or cytological confirmation of a
malignancy that is advanced (metastatic and unresectable) with measureable
disease and have at least 1 lesion that is biopsy-accessible.
For parts 1A and 1B
Subjects must have received, and then progressed or been intolerant to, at
least 1 standard treatment regimen in the advanced or metastatic setting, if
such a therapy exists. Subjects who refuse or are ineligible for standard
therapy will be allowed to enroll provided their refusal/ineligibility is
documented in medical records
All solid tumor histologies will be permitted except for subjects with primary
CNS tumors or with CNS metastases as the only site of active disease.
For Part 2
Subjects must have either NSCLC, RCC, CRPC, SCCHN, melanoma or pancreatic
cancer.
Subjects must have received, and then progressed or been intolerant to, at
least 1 standard treatment regimen.
All Subjects
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance
status of * 1.
Subjects who have prior exposure to any agent specifically targeting checkpoint
pathway inhibition or any agent specifically targeting T-cell co-stimulation
pathways are permitted after at least a 4 week washout period.
Prior palliative radiotherapy must have been completed at least 2 weeks prior
to first dose of the study drug.
Subjects must have adequate organ function
Ability to comply with treatment, PK, immunogenicity, biomarker, and PD sample
collection, and required study follow-up.
Subjects with known or suspected CNS metastases, untreated CNS metastases, or
with the CNS as the only site of disease are excluded.
Subjects with carcinomatous meningitis are excluded
Subjects who have participated in any prior clinical study with nivolumab in
which OS is listed as the primary or co primary endpoint and which has not
completed analysis based on the primary endpoint are excluded.
For subjects with pancreatic cancer those subjects with clinically relevant
ascites at baseline or with moderate radiographic ascites are excluded.
Subjects with a prior malignancy, different from the one used for enrolment in
this study, diagnosed less than 2 years ago are excluded.
Any anti-cancer therapy within 4 weeks of the start of study drug
Subjects who have received prior therapy with an anti-CD73 antibody, an
anti-CD39 antibody, or an adenosine 2A receptor inhibitor are excluded
Subjects with active, known or suspected autoimmune disease.
Subjects with interstitial lung disease or chronic obstructive pulmonary disease
Subjects with a condition requiring systemic treatment with either
corticosteroids (> 10 mg daily prednisone equivalents) or other
immunosuppressive medications
Subjects with uncontrolled or significant cardiovascular disease
Subjects with active hepatitis, active bacterial, viral, or fungal infections,
a known history of testing positive for human immunodeficiency virus (HIV)
Subjects who have undergone any major surgery within 4 weeks of study drug
administration are excluded
Subjects with a history of any significant drug allergy or ongoing adverse
events.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety Outcome Measures:<br /><br>Safety assessment will be based on comprehensive medical review of adverse<br /><br>events, vital signs, ECGs, physical examinations and the results of laboratory<br /><br>tests. Adverse events will be assessed continuously during the study and for<br /><br>100 days after the last treatment The incidence of observed adverse events will<br /><br>be tabulated and reviewed for potential significance and clinical importance. </p><br>
- Secondary Outcome Measures
Name Time Method