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

Pancreatic Cancer Clinical Trial

— NivoPlus  

Official title:

A Phase Ib/II Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02423954
• Other study ID #: WG2015001
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 2015
• Est. completion date: November 1, 2017

Study information

• Verified date: June 2018
• Source: Western Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine Phase 2 dose of study drug

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (www.nccn.org) 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Colorectal Carcinoma
• Colorectal Neoplasms
• Endometrial
• Neoplasms
• Non Small Cell Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Renal Cell Cancer
• Uterine

Intervention

Drug:
• Temsirolimus

• Irinotecan

• Irinotecan + capecitabine

• nivolumab

Locations

Country	Name	City	State
United States	Cancer Treatment Center of America @ Western Regional Medical Center	Goodyear	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Western Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03	Identify adverse Events	up to 12 months
Secondary	Response rate by irRC and response evaluation criteria in solid tumors (RECIST) 1.1 criteria1,2	Identify tumor response	12 weeks
Secondary	The overall survival (OS) and progression-free survival (PFS)	Assess time until death after treatment	up to 12 months
Secondary	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