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

Solid Tumor Clinical Trial

— CXCessoR4  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02472977
• Other study ID #: CA212-115
• Secondary ID: 2015-000136-15
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 13, 2015
• Est. completion date: January 27, 2017

Study information

• Verified date: October 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

• Intervention model: Single group for Stage 1 DLT, then Parallel

• Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: January 27, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• SCLC or PAC that is advanced or has spread to other parts of the body

• Treated with at least one other chemotherapy that did not work or where cancer relapsed

• Minimal limitations on activities of daily living as measured by Eastern Cooperative Oncology Group (ECOG) score of 0-1

Exclusion Criteria:

• Patients with cancer that spread to the brain

• Active, known or suspected autoimmune disease

• Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• Ulocuplumab

• Nivolumab

Locations

Country	Name	City	State
Finland	Local Institution	Helsinki
United States	University Of Colorado Hosp	Aurora	Colorado
United States	Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins	Baltimore	Maryland
United States	Indiana University Health	Indianapolis	Indiana
United States	Columbia University Medical Center (Cumc)	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs	The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.	From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
Primary	Objective Response Rate (ORR) Per RECIST 1.1 Criteria	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.	From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)
Primary	Overall Survival (OS)	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.	From date of randomization to date of death (assessed up to study completion, approximately 18 months)
Primary	Number of Participants With Laboratory Abnormalities	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.	From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
Primary	Number of Participants With Electrocardiogram Abnormalities	The number of participants experiencing electrocardiogram abnormalities was reported for each arm	From first dose to date of last dose plus 30 days
Secondary	Progression-Free Survival (PFS)	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.	From first dose to date of progression (assessed up to January 2017, approximately 18 months)

External Links

•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form