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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Western Regional Medical Center
Information provided by (Responsible Party):
Western Regional Medical Center Identifier:
First received: April 13, 2015
Last updated: December 10, 2015
Last verified: December 2015
Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer.

Condition Intervention Phase
Advanced Cancer
Pancreatic Cancer
Renal Cell Cancer
Non Small Cell Lung Cancer
Colorectal Carcinoma
Drug: Temsirolimus
Drug: Irinotecan
Drug: Irinotecan + capecitabine
Drug: nivolumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib/II Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)

Resource links provided by NLM:

Further study details as provided by Western Regional Medical Center:

Primary Outcome Measures:
  • The recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer. [ Time Frame: up to 4 weeks ]

Secondary Outcome Measures:
  • Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 [ Time Frame: up to 12 months ]
  • Response rate by irRC and response evaluation criteria in solid tumors (RECIST) 1.1 criteria1,2 [ Time Frame: 12 weeks ]
  • The overall survival (OS) and progression-free survival (PFS) [ Time Frame: up to 12 months ]
  • Quantify changes in amount of blood proteins and circulating tumor DNA in patients enrolled on this study [ Time Frame: up to 12 months ]
  • Quantify pixel changes identified on imaging [ Time Frame: 12 weeks ]

Estimated Enrollment: 49
Study Start Date: April 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Temsirolimus 25 mg every 14 days.
Drug: Temsirolimus Drug: nivolumab
Experimental: Arm 2
Irinotecan 150 mg/m2 every 14 days.
Drug: Irinotecan Drug: nivolumab
Experimental: Arm 3
Modified biweekly XELIRI 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria for Phase Ib and II:

  1. Patient at least 18 years old and has definitive histologically or cytologically confirmed metastatic solid tumor.
  2. Patient has one or more metastatic tumors measurable by CT scan (or PET/CT, if patient is allergic to CT contrast media). Tumor sites that are considered measureable must not have received prior radiation therapy. For metastatic tumors not measurable by CT and/or PET/CT, there needs to be tumor measuring at least 1cm in one dimension by digital calipers on physical exam.
  3. Patients can be enrolled only on one of the treatment arms on this trial.
  4. The investigator will select the appropriate treatment arm for the patient with the following requirements: (a) Patients cannot have had prior progression or intolerance on the single agent chemotherapy and then enrolled on an arm with that same single agent chemotherapy plus nivolumab (b) The chemotherapy on the arm selected must be considered standard of care or its components listed in the NCCN guidelines ( for that cancer type.
  5. Have recovered from acute toxicities of prior treatment:

    • > 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:

    [CreatClear = Sex * ((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.

Exclusion Criteria for Phase Ib and II:

  1. Active clinically serious infection > CTCAE (version 4.03) Grade 2.
  2. Serious non-healing wound, ulcer, or bone fracture.
  3. Patient has known brain metastases. Baseline imaging of the brain is required within 28 days prior to randomization.
  4. Prior therapy with a mammalian target of rapamycin (mTOR) inhibitor for the RCC subjects, prior therapy with irinotecan or topotecan for NSCLC subjects, and prior therapy with irinotecan for CRC patients.
  5. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
  6. Patient has known active infection with HIV, hepatitis B, or hepatitis C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol).
  7. Requiring daily corticosteroid dose ≥ 10 mg prednisone or equivalent per day.
  8. Patient has undergone major surgery, other than diagnostic surgery (e.g., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
  9. Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
  10. Patient will be receiving any other anti-cancer therapy during participation in this trial.
  11. Prior treatment with nivolumab is not allowed. Prior receipt of other PD-1 inhibitors or PD-L1 inhibitors is allowed.
  12. Active or prior documented autoimmune disease requiring systemic treatment within the past 2 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02423954

Contact: Research Nurse, RN 6232073000

United States, Arizona
Cancer Treatment Center of America @ Western Regional Medical Center Recruiting
Goodyear, Arizona, United States, 85338
Contact: Research Nurse    623-207-3000   
Sub-Investigator: Glen Weiss, MD, MBA         
Principal Investigator: Vivek Khemka, MD, MBA         
Sponsors and Collaborators
Western Regional Medical Center
Principal Investigator: Vivek Khemka, MD, MBA Western Regional Medical Center
  More Information

Responsible Party: Western Regional Medical Center Identifier: NCT02423954     History of Changes
Other Study ID Numbers: WG2015001
Study First Received: April 13, 2015
Last Updated: December 10, 2015

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Carcinoma, Renal Cell
Colorectal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases processed this record on April 24, 2017