Not provided
Not provided
Not provided
Not provided
Not provided
PI not longer at site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks Gemcitabine 1000 mg/m2 on day 1 and day 8 every 21 days |
|
| Arm 2 | Experimental | 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 |
|
| Arm 3 | Experimental | 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 |
|
| Arm 4 | Experimental | 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 |
|
| Arm 5 | Experimental | Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks Irinotecan 300 mg/m2 on day 1 every 21 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the recommended phase 2 dose | Objective for phase Ib: Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with pembrolizumab (pembro) in subjects with advanced cancer. | 3 weeks |
Not provided
Not provided
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:
> 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 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
Exclusion Criteria:
1. Patients with a history of more than one primary cancer, with the exception of:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ashish Sangal, MD | Western Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Treatment Center of America @ Western Regional Medical Center | Goodyear | Arizona | 85338 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29119276 | Derived | Weiss GJ, Blaydorn L, Beck J, Bornemann-Kolatzki K, Urnovitz H, Schutz E, Khemka V. Phase Ib/II study of gemcitabine, nab-paclitaxel, and pembrolizumab in metastatic pancreatic adenocarcinoma. Invest New Drugs. 2018 Feb;36(1):96-102. doi: 10.1007/s10637-017-0525-1. Epub 2017 Nov 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Arm 6 | Experimental | Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks Liposomal doxorubicin 30 mg/m2 on day 1 every 21 days |
|
| Gemcitabine | Drug |
|
|
| Docetaxel | Drug |
|
|
| Nab-paclitaxel | Drug |
|
|
| Vinorelbine | Drug |
|
|
| Irinotecan | Drug |
|
|
| Liposomal Doxorubicin | Drug |
|
|
| Western Regional Medical Center |
| Goodyear |
| Arizona |
| 85338 |
| United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D012509 | Sarcoma |
| D010190 | Pancreatic Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000077235 | Vinorelbine |
| D000077146 | Irinotecan |
| C506643 | liposomal doxorubicin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017239 | Paclitaxel |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D002166 | Camptothecin |
Not provided
Not provided