Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)

Phase 1

Terminated

• Conditions: Colorectal Carcinoma; Advanced Cancer; Pancreatic Cancer; Renal Cell Cancer; Uterine; Non Small Cell Lung Cancer; Endometrial
• Interventions: Drug: Irinotecan + capecitabine; Drug: Irinotecan; Drug: Temsirolimus; Drug: nivolumab

• Registration Number: NCT02423954
• Lead Sponsor: Western Regional Medical Center

Brief Summary

Determine Phase 2 dose of study drug

Detailed Description

Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Primary Completion: 2017-11-01
• Study Completion: 2017-11-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-28
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 2	nivolumab	Irinotecan 150 mg/m2 every 14 days + nivolumab
Arm 3	Irinotecan + capecitabine	Irinotecan + capecitabine + nivolumab irinotecan 175 mg/m2 on day 1 every 14 days + capecitabine 1000 mg PO BID days 1-5 on, days 6-7 off, each 7 day period
Arm 2	Irinotecan	Irinotecan 150 mg/m2 every 14 days + nivolumab
Arm 1	Temsirolimus	Temsirolimus 25 mg every 14 days + nivolumab
Arm 1	nivolumab	Temsirolimus 25 mg every 14 days + nivolumab
Arm 3	nivolumab	Irinotecan + capecitabine + nivolumab irinotecan 175 mg/m2 on day 1 every 14 days + capecitabine 1000 mg PO BID days 1-5 on, days 6-7 off, each 7 day period

Primary Outcome Measures

Name	Time	Method
The recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.	up to 4 weeks	phase 2 dosing of nivolumab + chemotherapy

Secondary Outcome Measures

Name	Time	Method
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03	up to 12 months	Identify adverse Events
Response rate by irRC and response evaluation criteria in solid tumors (RECIST) 1.1 criteria1,2	12 weeks	Identify tumor response
Quantify changes in amount of blood proteins and circulating tumor DNA in patients enrolled on this study	up to 12 months	Assess tumor marker levels
The overall survival (OS) and progression-free survival (PFS)	up to 12 months	Assess time until death after treatment

Trial Locations

Locations (1)

Cancer Treatment Center of America @ Western Regional Medical Center; 🇺🇸 Goodyear, Arizona, United States