Study Of Nivolumab Plus Chemotherapy In Patients With Advanced Cancer (NivoPlus)

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-04-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-06-28
First Submitted that Met QC Criteria 2015-04-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-07-02
First Posted (ACTUAL) 2015-04-22	Results First Posted N/A	Last Verified 2018-06

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1 Temsirolimus 25 mg every 14 days + nivolumab	DRUG: Temsirolimus DRUG: nivolumab
EXPERIMENTAL: Arm 2 Irinotecan 150 mg/m2 every 14 days + nivolumab	DRUG: Irinotecan DRUG: nivolumab
EXPERIMENTAL: Arm 3 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	DRUG: Irinotecan + capecitabine DRUG: nivolumab

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm 1

Temsirolimus 25 mg every 14 days + nivolumab

DRUG: Temsirolimus

DRUG: nivolumab

EXPERIMENTAL: Arm 2

Irinotecan 150 mg/m2 every 14 days + nivolumab

DRUG: Irinotecan

DRUG: nivolumab

EXPERIMENTAL: Arm 3

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

DRUG: Irinotecan + capecitabine

DRUG: nivolumab

Primary Outcome Measures	Measure Description	Time Frame
The recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.	phase 2 dosing of nivolumab + chemotherapy	up to 4 weeks

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

> 3 weeks must have elapsed since receiving any investigational agent.
> 2 weeks must have elapsed since receiving any radiotherapy, or ≥ 3 weeks or 5 half-lives whichever is shorter for treatment with cytotoxic or biologic agents ( ≥ 6 weeks for mitomycin or nitrosoureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted. 6. Patient has adequate biological parameters as demonstrated by the following blood counts at time of screening: 7. Absolute neutrophil count (ANC) > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 9 g/dL. Subject can be given packed red blood cell transfusion 8. Calculated creatinine clearance > 40 ml/min by Cockroft-Gault equation:

((140 - Age) / (SerumCreat))
(Weight / 72); where Sex = 1 for men and 0.85 for women], total bilirubin 1.5 times the upper limit of normal (ULN) range, AST/ALT ≤ 3 times the upper limit of normal (ULN) range. 9. Thyroid stimulating hormone (TSH) within institutional normal limits. If TSH is above the upper limit of normal range, then a free T4 within institutional normal limits is acceptable. If thyroid replacement therapy is initiated then patient may be screened and enrolled once the above criterion is met. 10. Persistent prior systemic therapy non-hematologic AE grade ≤ 2 (except alopecia or correctable electrolyte abnormality with supplementation) 11. Patient has a Karnofsky performance status (KPS) ≥ 70. 12. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 5 months following the last dose of nivolumab and 30 days following the last dose of chemotherapy on this trial on this trial, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial. If a female subject or female partner of a male subject becomes pregnant during this period then patient will be recommended to seek appropriate obstetric care. The study will not be monitoring subjects or female partners of subjects for pregnancy after the last dose of study drug or chemotherapy.

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Resources

PatientS

Caregivers

Clinical Trial Record