We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03872947
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : October 4, 2022
Sponsor:
Information provided by (Responsible Party):
Toray Industries, Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, Gemcitabine / Carboplatin / Bevacizumab, Topotecan, and Pegylated liposomal doxorubicin (PLD) for selected advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Colorectal Cancer Cholangiocarcinoma Bladder Cancer Ovarian Cancer Gastric Cancer Palpable Subcutaneous Malignant Lesions Renal Cell Carcinoma Melanoma Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Biological: TRK-950 Drug: Irinotecan Drug: Leucovorin Drug: 5-FU Drug: Gemcitabine Drug: Cisplatin Drug: Carboplatin Biological: Ramucirumab Drug: Paclitaxel Biological: Nivolumab Biological: Pembrolizumab Drug: Imiquimod Cream Biological: Bevacizumab Drug: Topotecan Drug: PLD Phase 1

Expanded Access : Toray Industries, Inc has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Detailed Description:
This study is an open-label, Phase 1b study evaluating TRK-950 in combination with 1) FOLFIRI or 2) Gemcitabine / Cisplatin or 3) Gemcitabine / Carboplatin or 4) Ramucirumab/Paclitaxel or 5) PD1 inhibitors (Nivolumab or Pembrolizumab) or 6) Imiquimod Cream for subcutaneous lesions 7) Bevacizumab 8) Gemcitabine / Carboplatin / Bevacizumab, 9) Topotecan, or 10) PLD in Patients with Selected Advanced Solid Tumors. The objectives of this study are to determine the safety, tolerability, MTD, recommended Phase 2 dose (RP2D), PK, and preliminary anti-tumor activity of TRK-950 when used in combination with other treatment regimens.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 169 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 When Used in Combinations With Selected Anti-Cancer Treatment Regimens in Patients With Selected Advanced Solid Tumors
Actual Study Start Date : April 26, 2019
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Arm A: TRK-950 + FOLFIRI
  • Colorectal Cancer
  • TRK-950 will be administered intravenously (IV) on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.
 Biological: TRK-950
Intravenously over 60 minutes

Drug: Irinotecan
Intravenously over 30 - 90 minutes

Drug: Leucovorin
Intravenously over 30 - 90 minutes

Drug: 5-FU
Intravenously bolus and intravenously for two days
Experimental: Arm B: TRK-950 + Gemcitabine/Cisplatin
  • Cholangiocarcinoma or Bladder Cancer
  • TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Cisplatin will be administered by infusion. Then, Gemcitabine will be administered as an IV infusion.
 Biological: TRK-950
Intravenously over 60 minutes

Drug: Gemcitabine
Intravenously over 30 minutes

Drug: Cisplatin
Intravenously over 60 minutes
Experimental: Arm C: TRK-950 + Gemcitabine/Carboplatin
  • Ovarian Cancer
  • TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Gemcitabine will be administered as an intravenous infusion. On day 1, following the administration of TRK-950 and Gemcitabine, Carboplatin will be administered IV.
 Biological: TRK-950
Intravenously over 60 minutes

Drug: Gemcitabine
Intravenously over 30 minutes

Drug: Carboplatin
Intravenously per package insert
Experimental: Arm D: TRK-950 + Ramucirumab/Paclitaxel
  • Gastric Cancer
  • TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Ramucirumab will be administered as an IV infusion. Paclitaxel will be dosed on days 1, 8 and 15, after the Ramucirumab on days 1 and 15 and after the TRK-950 on day 8.
 Biological: TRK-950
Intravenously over 60 minutes

Biological: Ramucirumab
Intravenously over 60 minutes

Drug: Paclitaxel
Intravenously
Experimental: Arm E: TRK-950 + PD1 inhibitors

•Solid Tumors

E-1: TRK-950 + Nivolumab

•TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion.

E-2: TRK-950 + Pembrolizumab

•TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.

 Biological: TRK-950
Intravenously over 60 minutes

Biological: Nivolumab
Intravenously over 30 minutes

Biological: Pembrolizumab
Intravenously over 30 minutes
Experimental: Arm F: TRK-950 + Imiquimod Cream
  • Palpable subcutaneous malignant lesions
  • TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. Imiquimod cream is to be applied 5 of 7 days in a row with 2 days rest for a maximum of 2 cycles (total 6 weeks).
 Biological: TRK-950
Intravenously over 60 minutes

Drug: Imiquimod Cream
Topically
Experimental: Arm G: TRK-950 + Bevacizumab
  • Renal Cell Carcinoma
  • TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Bevacizumab will be administered as an IV infusion.
 Biological: TRK-950
Intravenously over 60 minutes

Biological: Bevacizumab
Intravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses
Experimental: Arm H: TRK-950 + PD1 inhibitors

•Melanoma

H-1: TRK-950 + Nivolumab

•TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion.

H-2: TRK-950 + Pembrolizumab

•TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.

 Biological: TRK-950
Intravenously over 60 minutes

Biological: Nivolumab
Intravenously over 30 minutes

Biological: Pembrolizumab
Intravenously over 30 minutes
Experimental: Arm J: TRK-950 + FOLFIRI
  • Colorectal Cancer
  • TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.
 Biological: TRK-950
Intravenously over 60 minutes

Drug: Irinotecan
Intravenously over 30 - 90 minutes

Drug: Leucovorin
Intravenously over 30 - 90 minutes

Drug: 5-FU
Intravenously bolus and intravenously for two days
Experimental: Arm K: TRK-950(Lower-dose) + Gemcitabine / Carboplatin / Bevacizumab
  • Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer
  • TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. Gemcitabine will be administered as an intravenous infusion on days 1 and 8. On day 1, following the administration of Gemcitabine, Carboplatin will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. After 6 cycles of chemotherapy the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease.
 Biological: TRK-950
Intravenously over 60 minutes

Drug: Gemcitabine
Intravenously over 30 minutes

Drug: Carboplatin
Intravenously per package insert

Biological: Bevacizumab
Intravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses
Experimental: Arm M: TRK-950(Lower-dose) + Topotecan
  • Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer
  • TRK-950 will be administered IV on days 1, 8, 15 and 22 of a 28-day cycle. Topotecan will be administered as an intravenous infusion on days 1, 8, 15 of a 28-day cycle. On days 1, 8 and 15, TRK-950 will be administered IV after the topotecan infusion.
 Biological: TRK-950
Intravenously over 60 minutes

Drug: Topotecan
Intravenously over 30 minutes
Experimental: Arm O: TRK-950(Lower-dose) + PLD
  • Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer
  • TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. PLD will be dosed as IV on Day 1 of each cycle. On days that TRK-950 and PLD are both dosed, PLD will be dosed first.
 Biological: TRK-950
Intravenously over 60 minutes

Drug: PLD
Intravenously over 60 minutes
Experimental: Arm Q: TRK-950(Lower-dose) +Ramucirumab/Paclitaxel
  • Gastric cancer
  • TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. On days 1 and 15, ramucirumab will be administered IV. Paclitaxel will be dosed on days 1, 8 and 15, after ramucirumab on days 1 and 15, before TRK-950 on day 8.
 Biological: TRK-950
Intravenously over 60 minutes

Biological: Ramucirumab
Intravenously over 60 minutes

Drug: Paclitaxel
Intravenously
Experimental: Arm R: TRK-950(Lower-dose) +Bevacizumab
  • Renal cell carcinoma cancer
  • TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. Bevacizumab will be dosed as IV on Day 1 and 15 of each cycle. On days that TRK-950 and Bevacizumab are both dosed, Bevacizumab will be dosed first.
 Biological: TRK-950
Intravenously over 60 minutes

Biological: Bevacizumab
Intravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: through study completion, an average of 1 year ]
  2. Frequency of patients experiencing adverse events of special interest (AESIs) [ Time Frame: through study completion, an average of 1 year ]
  3. Blood pressure [ Time Frame: through study completion, an average of 1 year ]
    mmHg

  4. Heart rate [ Time Frame: through study completion, an average of 1 year ]
    bpm

  5. Respiratory rate [ Time Frame: through study completion, an average of 1 year ]
    bpm

  6. Temperature [ Time Frame: through study completion, an average of 1 year ]
    °F or °C

  7. Weight [ Time Frame: through study completion, an average of 1 year ]
    lbs/kg

  8. Height [ Time Frame: through study completion, an average of 1 year ]
    inches/cm

  9. Performance status using Karnofsky performance status criteria [ Time Frame: through study completion, an average of 1 year ]
  10. QTc interval determined from 12-lead Electrocardiogram [ Time Frame: through study completion, an average of 1 year ]
    msec

  11. QRS interval determined from 12-lead Electrocardiogram [ Time Frame: through study completion, an average of 1 year ]
    msec

  12. Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry) [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: through study completion, an average of 1 year ]
  2. Disease Control Rate (DCR) [ Time Frame: through study completion, an average of 1 year ]
  3. Serum concentration of TRK-950 [ Time Frame: through study completion, an average of 1 year ]
  4. Plasma concentration of Gemcitabine for the first six patients in Arm K [ Time Frame: At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days) ]
  5. Plasma concentration of Carboplatin for the first six patients in Arm K [ Time Frame: At the beginning of Cycle 1 and Cycle 4 (each cycle is 21 days) ]
  6. Serum concentration of Bevacizumab for the first six patients in Arm K [ Time Frame: At the beginning of Cycle 1, Cycle 2, Cycle 4 and Cycle 5 (each cycle is 21 days) ]
  7. Plasma concentration of Topotecan for the first six patients in Arm M [ Time Frame: At the beginning of Cycle 1 and Cycle 3 (each cycle is 28 days) ]
  8. Plasma concentration of PLD for the first six patients in Arm O [ Time Frame: At the beginning and middle of Cycle 1 and Cycle 3 (each cycle is 28 days) ]
  9. Serum concentration of Ramucirumab for the first six patients in Arm Q [ Time Frame: At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days) ]
  10. Plasma concentration of Paclitaxel for the first six patients in Arm Q [ Time Frame: At the beginning of Cycle 1 and Cycle 4 (each cycle is 28 days) ]
  11. Serum concentration of Bevacizumab for the first six patients in Arm R [ Time Frame: At the beginning and middle of Cycle 1 and Cycle 4 (each cycle is 28 days) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Histologically confirmed solid malignancy for which the following treatment regimens are warranted:
  • Arm A. Colorectal Cancer with no prior history of treatment with Irinotecan alone or in combination: FOLFIRI as standard of care
  • Arm B. Cholangiocarcinoma, Bladder Cancer with no prior history of treatment with Gemcitabine alone or in combination: Gemcitabine / Cisplatin as standard of care
  • Arm C and Expansion Cohort 1. Ovarian Cancer who have relapsed at least 6 or more months after completion of a previous platinum-based therapy and have no prior history of treatment with gemcitabine alone or in combination: Gemcitabine / Carboplatin as standard of care
  • Arm D and Expansion Cohort 2. Gastric Cancer including Gastroesophageal Junction with no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug: Ramucirumab / Paclitaxel as standard of care
  • Arm E. Solid Tumors: Eligible for PD1 Inhibitor (Nivolumab or Pembrolizumab) monotherapy as standard of care according to the approved drug label by the relevant regulatory authority
  • Arm F. Locally advanced or metastatic disease in a cancer with at least one palpable subcutaneous malignant lesion (≤ 2 cm in diameter) for treatment with TRK-950 and Imiquimod cream (US Sites Only)
  • Arm G. Renal Cell Carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment
  • Arm H. Melanoma patients who progressed while taking Nivolumab, Pembrolizumab, or Ipilimumab, within the last 6 months prior to cycle 1 day 1
  • Arm J. Colorectal Cancer patients who progressed on FOLFIRI or any other Irinotecan-containing therapy regimen within the last 6 months prior to cycle 1 day 1
  • Arm K. (US Sites Only). Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 2 prior treatment lines who have recurred > 6 months after most recent platinum-based chemotherapy and who are eligible for gemcitabine, carboplatin, and Bevacizumab as standard of care for dosing of TRK-950(Lower-dose)

  • Arms M and O. Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, as defined below and who are eligible for topotecan or pegylated liposomal doxorubicin as standard of care for dosing of TRK-950(Lower-dose)

    • Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response, and then progressed between 3 months and less than or equal to 6 months after the last date of platinum.
    • Patients who have received 2 to 5 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum.
    • Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy
  • Arm Q. Gastric Cancer including GEJ cancer with only 1 prior treatment regimen, which recurred during or within 4 months after frontline treatment, and no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug for metastatic disease: eligible to receive Ramucirumab/Paclitaxel as standard of care (Lower-dose)
  • Arm R. Clear cell renal cell carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment. (Lower-dose)
  • Primary or metastatic tumors measurable per RECIST v1.1 on CT scan or by calipers (subcutaneous lesions)
  • Karnofsky performance of ≥70
  • Life expectancy of at least 3 months
  • Age ≥ 18 years
  • Signed, written IRB-approved informed consent

Exclusion Criteria:

  • Laboratory values or medications that are contraindicated in the selected standard of care treatment regimens
  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Prophylactic antibiotics are acceptable.
  • Pregnant or nursing women
  • Treatment with radiation therapy within 2 weeks, or treatment with surgery, chemotherapy, immunotherapy, targeted therapy or investigational therapy within four weeks prior to initiation of study treatment (6 weeks for nitrosoureas or mitomycin C, and 2 weeks or 5 half-lives whichever is longer for TKIs).
  • Unwillingness or inability to comply with procedures required in this protocol
  • Known active infection with HIV, hepatitis B, hepatitis C
  • Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  • Patients who are currently receiving any other investigational agent
  • Any contraindicated condition or drug which would make the patient ineligible for the respective treatment regimen that is to be used in combination with TRK-950 (for example, autoimmune disorders for nivolumab or pembrolizumab treatment) as described in the Full Prescribing Information
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03872947


Contacts
Layout table for location contacts
Contact: Vicki Bauernschub, BSN, RN 602 358 8324 vbauernschub@td2inc.com

Locations
Layout table for location information
United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN,RN,AOCNS    480-323-1339      
AOA-HOPE Recruiting
Tucson, Arizona, United States, 85711
Contact: AOA-HOPE    520-886-0206      
Contact: Julie Klinker, BSN    (520)269-3821    Julie.klinker@usoncology.com   
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Xiomara Menendez, BSN, RN    323-409-4368    Xiomara.Menendez@med.usc.edu   
HOAG Memorial Hospital Presbyterian Recruiting
Newport, California, United States, 92663
Contact: Chi Nguyen, CCRP    949-764-6763    chi.nguyen@hoag.org   
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Amanda Woolery, RN       Amanda.woolery@ochsner.org   
United States, New Jersey
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Angela Alistar, Dr.    973-971-7960    Angela.Alistar@atlantichealth.org   
United States, New York
Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Priyanka Patel, BS       Priyanka.Patel@nyulangone.org   
Contact: Brianne Boljonis, BSN,RN       Brianne.Boljonis@nyulangone.org   
United States, Oregon
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center) Recruiting
Eugene, Oregon, United States, 97401
Contact: Oncology Associates of Oregon, P.C.    541-683-5001      
Contact: Jeanne Schaffer, RN-BSN       Jeanne.Schaffer@usoncology.com   
Northwest Cancer Specialists Recruiting
Portland, Oregon, United States, 97227
Contact: Northwest Cancer Specialists    503-528-5005      
Contact: Amber Holden, BA    (360)597-1300    amber.holden@compassoncology.com   
United States, Texas
Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Texas Oncology, P.A.    214-370-1000      
Contact: Rita Lopez, AS    (214)584-3236    rita.lopez2@usoncology.com   
Texas Oncology - Downtown Fort Worth Cancer Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Nori Sullivan, RN, BSN, CCRC    817-413-1760    nori.sullivan@usoncology.com   
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Leesburg, Virginia, United States, 20176
Contact: Virginia Cancer Specialists, PC    703-554-6800      
Contact: Carrie Friedman, Research Nurse Navigator    (703)636-1473    carrie.friedman@usoncology.com   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Medical College of Wisconsin    866-680-0505 ext 8900    cccto@mcw.edu   
Contact: Medical College of Wisconsin    414-805-8900      
France
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Philippe Cassier, M.D.    +33 (0)4 26 55 68 33      
Sponsors and Collaborators
Toray Industries, Inc
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT03872947    
Other Study ID Numbers: 950P1V02
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Carcinoma, Renal Cell
Cholangiocarcinoma
Fallopian Tube Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
 Carcinoma
Neoplasms, Glandular and Epithelial
Urologic Neoplasms
Urologic Diseases
Adenocarcinoma
Kidney Neoplasms
Kidney Diseases
Fallopian Tube Diseases
Leucovorin
Gemcitabine
Bevacizumab
Carboplatin
Pembrolizumab
Nivolumab
Irinotecan