Safety Study of Nivolumab With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer

Completed · Phase 1

Conditions studied: Breast Neoplasms, Pancreatic Neoplasms

In brief

The purpose of this study is to assess safety of nab-paclitaxel based chemotherapy regimens administered prior to and/or in combination with nivolumab in Pancreatic Cancer, Non Small Cell Lung Cancer (NSCLC) and Metastatic Breast Cancer (mBC).

Key facts

Study ID

NCT02309177

Run by

Celgene

People needed

114

Starts

2015-01-12

Expected to finish

2018-09-12

Last updated by the study team

2019-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is male or female, ≥ 18 years old at the time of signing the informed consent form (ICF).
• Subject has a confirmed diagnosis of advanced unresectable solid tumors in the target subject population within the parameters mentioned:
• Pancreatic Cancer
• Subject has a definitive histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas. Subjects with islet cell neoplasms are excluded.
• nab-Paclitaxel and Nivolumab: Subjects must have received 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease.
• nab-Paclitaxel + Nivolumab and nab-paclitaxel, Gemcitabine and Nivolumab: Subjects must have received no previous systemic chemotherapy or investigational therapy for the treatment of pancreatic adenocarcinoma, including neo-adjuvant or adjuvant therapy, with the exception of prior treatment administered as a radiosensitizer concomitant with radiotherapy in the adjuvant setting. In this case, ≥ 6 months must have elapsed since completion of the last dose and no lingering toxicities may be present. Initial diagnosis of metastatic disease must have occurred ≤ 6 weeks prior to randomization in the study.
• Non-small Cell Lung Cancer (NSCLC):
• Subject has definitive histologically or cytologically confirmed Stage IIIB or IV NSCLC.
• Subjects must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Adjuvant, neo-adjuvant chemotherapy or chemoradiotherapy is permitted providing cytotoxic chemotherapy was completed > 12 months prior to randomization, without disease recurrence or progression during those 12 months.
• Metastatic Breast Cancer: Human Epidermal Growth Factor Receptor 2 - negative (HER2(-)) recurrent Metastatic Breast Cancer:
• Subject has a definitive histologically or cytologically confirmed diagnosis of HER2(-) metastatic breast cancer.
• Subject has received zero to one prior cytotoxic chemotherapy regimen for metastatic disease, regardless of prior targeted therapy (eg. everolimus, palbociclib or lapatinib), biologic (eg. trastuzumab) or hormonal therapy treatment (eg. aromatase inhibitors, selective estrogen receptor modulators, or estrogen receptor down-regulators).
• If subject has received solvent-based paclitaxel (TAXOL) or docetaxel as adjuvant chemotherapy, subject must not have relapsed with breast cancer within 12 months of completing said therapy.
• Suitable candidate for single agent nab-paclitaxel as assessed by the investigator.
• Subject has measurable disease according to RECIST 1.1. 4. Archival formalin-fixed, paraffin-embedded tumor sample collected within 90 days prior to subject consent available or subject has biopsiable metastatic lesion and is willing to undergo biopsy .
• Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Subject has no other malignancy within 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in-situ cervical cancer or incidental histological finding of prostate cancer (TNM stage of T1a or T1b); all treatments of which should have been completed 6 months prior to signing ICF.
• Subject has the following laboratory values at screening:
• WBCs ≥ 2000/uL,
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L,
• Hemoglobin (Hgb) ≥ 90 g/L,
• Platelets (plt) ≥ 100 x 109/L,
• Potassium within normal range, or correctable with supplements,
• Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 3.0 x ULN if liver tumor is present,
• Serum total bilirubin ≤ 1.5 x ULN (except in subjects with Gilbert's who may have serum bilirubin < 3.0 x ULN),

You may not qualify if…

• Subject has a history of allergy or hypersensitivity to any study drugs or their excipients.
• Subject has had prior therapy with T-cell immune modulating antibodies, including anti-CTLA-4, anti-PD-1 or anti-PD-L1.
• Subject has symptomatic brain metastases, spinal cord compression, or intractable back pain due to compression of destructive mass.
• Subject has active, known or suspected autoimmune disease, including systemic lupus erythematodes, Hashimotos thyroiditis, scleroderma, polyarteritis nodosa or auto-immune hepatitis. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Subject is currently receiving or requires treatment with immunosuppressive agents or immunosuppressive doses of systemic corticosteroids (unless used to treat drug-related adverse events).Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption), and some uses of systemic corticosteroids are permitted as per Section 9.1.
• Subject has any peripheral neuropathy ≥ NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events ) Grade 2 at randomization/enrollment.
• Subject has a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies. Any lung disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
• Subject has a high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
• Subject has unstable angina, a significant cardiac arrhythmia, or New York Heart Association Class 3 or 4 congestive heart failure.
• Subject has a history of peripheral artery disease (eg, claudication, Leo Buerger's disease).
• Subject has had major surgery, other than diagnostic surgery, within 4 weeks prior to treatment in study.
• Subject has known acute or chronic pancreatitis.
• Subject has persistent diarrhea, malabsorption, or known sub-acute bowel obstruction ≥ NCI CTCAE Grade 2, despite medical management.
• Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• Subject has any history of testing positive for Human Immunodeficiency Virus (HIV) or known acquired immunodeficiency disorder (AIDS).
• Subject has active hepatitis B or C. Subject with hepatitis in medical history may be eligible if infection considered cleared, ie core Ab+, surface Ab+, surface Ag- for hep B and Ab+/DNA- for hep C.
• Subject is pregnant or breast-feeding. Women must not breast-feed until at 5 months after completion of study participation..
• Subject is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.
• Subject is currently using or use within 6 months of illicit drugs.
• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Subject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Subject has any condition that confounds the ability to interpret data from the study.

Where it is running

• UC Davis Cancer Center — Sacramento, California, United States
• University of California Los Angeles — Santa Monica, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer Center and Research Institute University of South Florida — Tampa, Florida, United States
• Northwestern University-NMDTI — Chicago, Illinois, United States
• Dana-Farber / Harvard Cancer Institute — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Regional Care Cancer Centers NJ — Morristown, New Jersey, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• Ohio State Medical Center — Columbus, Ohio, United States
• University of Pennslyvania — Philadelphia, Pennsylvania, United States
• Seattle Cancer Center Alliance — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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