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

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Western Regional Medical Center
Study ID
NCT02331251
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
  • Gemcitabine — DRUG
  • Docetaxel — DRUG
  • Nab-paclitaxel — DRUG
  • Vinorelbine — DRUG
  • Irinotecan — DRUG
  • Liposomal Doxorubicin — DRUG

Study Details

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.

Key Dates

Start date
Dec 31, 2014
Status verified
Jun 2018
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018

Study Design

Enrollment
81 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Determine the recommended phase 2 dose [ Time Frame: 3 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Cancer Treatment Center of America @ Western Regional Medical CenterGoodyearArizona85338-
Western Regional Medical CenterGoodyearArizona85338-

Find similar trials in Goodyear, AZ

By condition
Breast cancerPancreatic cancerLung cancer
By specialty
OncologyBreast oncologyWomen's healthGI oncologyLung oncologyLung disease
By research site
Cancer Treatment Center of America @ Western Regional Medical Center· Goodyear, AZWestern Regional Medical Center· Goodyear, AZ

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