Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Ulocuplumab

Bristol-Myers Squibb

The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.

* Intervention model: Single group for Stage 1 DLT, then Parallel
* Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)

Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors

A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined With Nivolumab in Subjects With Advanced or Metastatic Solid Tumors

The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.

ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.

If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.

The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.

The number of participants experiencing electrocardiogram abnormalities was reported for each arm

Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants.

Pancreatic Adenocarcinoma (PAC) Dose level 1, 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W

PAC DL1 (DLT)

Pancreatic Adenocarcinoma (PAC) Dose level -1, 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W

PAC DL-1 (Tot)

All Small Cell Lung Cancer (SCLC) subjects in study, 1 subject received 400 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W and 7 subjects received 200 mg ulocuplumab QW + 3 mg/kg nivolumab Q2W

SCLC (Tot)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Bristol-Myers Squibb Study Director

Adverse Events

Serious Adverse Events

Immune-mediated AEs

All treated participants. Participants in the SCLC (Tot) Arm were not evaluated for Immune-mediated AEs

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs

All treated participants in PAC arms. ORR data was not collected for SCLC arm.

Objective Response Rate (ORR) Per RECIST 1.1 Criteria

OS data was not collected for any participants

Overall Survival (OS)

Increased lymphocytes

Decreased platelet count

Hemoglobin

Leukocytes

Neutrophils

Platelet Count

Alanine Aminotransferase

Alkaline Phosphatase

Aspartate Aminotransferase

Bilirubin

Creatine

Hypernatremia

Hyponatremia

Hypermagnesemia

Hypomagnesemia

Hypercalcemia

Hypocalcemia

Hyperkalemia

Hypokalemia

Amylase

Lipase

All treated participants in PAC arms. Lab abnormality data was not collected for SCLC arm.

Spots Global Cancer Trial Database for Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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