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Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus)

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ClinicalTrials.gov Identifier: NCT02331251
Recruitment Status : Terminated (PI not longer at site.)
First Posted : January 6, 2015
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

Brief Summary:

The Phase Ib and II cohorts will enroll patients with metistatic solid tumors.

Phase II only will enroll the following patients:

Patients with metastatic sarcoma to be enrolled in the following 4 arms: pembro plus gemcitabine, pembro plus gemcitabine and docetaxel, pembro plus gemcitabine and vinorelbine, and pembro plus liposomal doxorubicin.

Patients with metastatic pancreatic adenocarcinoma to be enrolled in the pembro plus gemcitabine and nab-paclitaxel arm.

Patients with extensive-stage small cell lung cancer to be enrolled in the pembro plus irinotecan arm.

Patients with ER+ breast cancer to be enrolled in the pembro and vinorelbine arm.

Patients with ovarian cancer to be enrolled in the pembroplus liposomal doxorubicin arm.

Patients with metastatic TNBC (ER/PR/HER2 negative) to be enrolled in the pembro plus gemcitabine arm.


Condition or disease Intervention/treatment Phase
Advanced Cancer Breast Cancer Sarcoma Pancreatic Cancer Small Cell Lung Cancer Ovarian Drug: Pembrolizumab Drug: Gemcitabine Drug: Docetaxel Drug: Nab-paclitaxel Drug: Vinorelbine Drug: Irinotecan Drug: Liposomal Doxorubicin Phase 1 Phase 2

Detailed Description:
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus)
Actual Study Start Date : December 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018


Arm Intervention/treatment
Experimental: Arm 1
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks Gemcitabine 1000 mg/m2 on day 1 and day 8 every 21 days
Drug: Pembrolizumab
Other Name: Keytruda

Drug: Gemcitabine
Other Name: Gemzar

Experimental: Arm 2
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks Gemcitabine 900 mg/m2 on day 1 and 8 and docetaxel 75 mg/m2 on day 8 every 21 days
Drug: Pembrolizumab
Other Name: Keytruda

Drug: Gemcitabine
Other Name: Gemzar

Drug: Docetaxel
Other Name: Taxotere

Experimental: Arm 3
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks Gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 on day 1 and day 8 every 21 days
Drug: Pembrolizumab
Other Name: Keytruda

Drug: Gemcitabine
Other Name: Gemzar

Drug: Nab-paclitaxel
Other Name: Abraxane

Experimental: Arm 4
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks Gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on day 1 and day 8 every 21 days
Drug: Pembrolizumab
Other Name: Keytruda

Drug: Gemcitabine
Other Name: Gemzar

Drug: Vinorelbine
Other Name: Navelbine

Experimental: Arm 5
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks Irinotecan 300 mg/m2 on day 1 every 21 days
Drug: Pembrolizumab
Other Name: Keytruda

Drug: Irinotecan
Other Name: Camptosar

Experimental: Arm 6
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks Liposomal doxorubicin 30 mg/m2 on day 1 every 21 days
Drug: Pembrolizumab
Other Name: Keytruda

Drug: Liposomal Doxorubicin
Other Name: Doxil




Primary Outcome Measures :
  1. Determine the recommended phase 2 dose [ Time Frame: 3 weeks ]
    Objective for phase Ib: Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with pembrolizumab (pembro) in subjects with advanced cancer.



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

Inclusion Criteria:

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) 3. 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 pembro (b) The chemotherapy on the arm selected must be considered standard of care or listed in the NCCN guidelines (www.nccn.org) for that cancer type 4. Have recovered from acute toxicities of prior treatment:

  1. > 3 weeks must have elapsed since receiving any investigational agent
  2. > 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 5. Patient has adequate biological parameters as demonstrated by the following blood counts at time of screening: 6. Absolute neutrophil count (ANC) > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 9 g/dL 7. Serum creatinine ≤2.0, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal (ULN) range (except: for the nab-paclitaxel containing arm, bilirubin ≤ 1.25 times the ULN and for the docetaxel containing arm, bilirubin must be within institutional normal limits and AST/ALT ≤ 1.5 times the ULN) 8. 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 9. Persistent prior systemic therapy non-hematologic AE grade ≥ 2 (except alopecia or correctable electrolyte abnormality with supplementation) 10. Patient has a Karnofsky performance status (KPS) ≥ 70 11. 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 4 months following the last dose of pembrolizumab and 30 days following the last dose of chemotherapy on this trial, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial Phase II only

    1. Patients must have metastatic sarcoma to be enrolled in the following 4 arms: pembro plus gemcitabine, pembro plus gemcitabine and docetaxel, pembro plus gemcitabine and vinorelbine, and pembro plus liposomal doxorubicin
    2. Patients must have metastatic pancreatic adenocarcinoma to be enrolled in the pembro plus gemcitabine and nab-paclitaxel arm
    3. Patients must have extensive-stage small cell lung cancer to be enrolled in the pembro plus irinotecan arm

Exclusion Criteria:

  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, unless previously treated and well-controlled for at least 1 month (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart)
  4. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
  5. 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)
  6. Requiring daily corticosteroid dose ≥ 10 mg prednisone or equivalent per day
  7. 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
  8. Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindication or Special Warnings and Precautions sections of the product or comparator SmPC or Prescribing Information
  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 pembro. 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 Phase II portion only

1. Patients with a history of more than one primary cancer, with the exception of:

  1. curatively resected nonmelanomatous skin cancer;
  2. curatively treated cervical carcinoma in-situ; or
  3. other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the 2 years prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331251


Locations
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United States, Arizona
Cancer Treatment Center of America @ Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
Investigators
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Principal Investigator: Ashish Sangal, MD Western Regional Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT02331251     History of Changes
Other Study ID Numbers: PembroPlus
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Small Cell Lung Carcinoma
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Vinorelbine
Docetaxel
Gemcitabine
Pembrolizumab
Doxorubicin
Liposomal doxorubicin
Irinotecan
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators