Ovarian Cancer

Anti PD-1 Therapy in Combination with Platinum Chemotherapy for Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Patient Population

Main Criteria Only

  • Patients who have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who had a complete response to primary treatment of platinum based chemotherapy, have progressed within 6 months of completing platinum based chemotherapy and have subsequently received at least one, non-platinum, cytotoxic chemotherapy agent
  • Have relapsed, refractory or progressive disease following last line of treatment
  • Have measurable disease with at least 1 unidimensional lesion based on RECIST 1.1
  • Have a performance status of 0 to 1 on the ECOG Performance Scale
  • Demonstrate adequate organ function

Number of Patients

  • Up to 27 patients

Study Objectives

Primary Objectives

  • To determine the clinical response rate of platinum chemotherapy and pembrolizumab in platinum chemotherapy pretreated ovarian, fallopian tube and primary peritoneal cancer
  • To examine whether retreatment with platinum chemotherapy in platinum resistant ovarian, fallopian tube and primary peritoneal cancers improves progression free survival by concurrent administration of pembrolizumab

Treatment Information

After all screening procedures have been completed, pembrolizumab 200mg will be administered as a 30-minute IV infusion on Day 1 of each 3-week cycle. Carboplatin will be administered as a 30-minute IV infusion on Day 8 and Day 15 of each 3-week cycle.

On-Site Study Visits

  • The trial drug, pembrolizumab will be administered at the University of Washington Medical Center Clinical Research Center on Day 1 of each 21 day cycle. Carboplatin will be administered per standard of care at the patient’s own oncology clinic.
  • The treatment period is to repeat the 3-week cycles for up to 2 years.
  • Patients may be taken off treatment including but not limited to progression and unacceptable adverse events.
  • Tumor imaging will be arranged every 3 cycles per standard of care.

Long-Term Follow-up

  • A follow-up 30 day evaluation will be performed upon study completion
  • Following the 30 days, efforts will be made to collect radiologic imaging reports every 3 months for 1 year to monitor disease status
  • After a year total in the follow-up phase, radiologic imaging reports will be collected every 6 months

Other Procedures During Study Visits

  • History and physical exam
  • Clinical blood tests plus research blood collection for immune monitoring

Study Location:

University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195

ClinicalTrials.gov Identifier: NCT03029598

Contact Information:
866-932-8588

Email

trialtvg@uw.edu

 

A Phase II Study of Concurrent IGFBP-2 Vaccination and Neoadjuvant Chemotherapy to Increase the Rate of Pathologic Complete Response at the Time of Cytoreductive Surgery

Patient Population

Main Criteria Only

  • Patients with newly diagnosed ovarian, fallopian tube or peritoneal cancer that are recommended to receive neoadjuvant chemotherapy with carboplatin and paclitaxel with subsequent cytoreductive surgery.
  • Demonstrate adequate organ function.
  • Have a performance status of 0 to 2 on the ECOG Performance Scale.

Number of Patients

  • A total of 56 patients will be enrolled in two stages.

Study Objectives

Primary Objective

  • To determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases the rate of complete response induction.

Secondary Objective

  • To determine whether the addition of an IGFBP-2 vaccine to neoadjuvant chemotherapy increases progression free survival at 12 months.

Treatment Information

  • After all screening procedures have been completed (consent, blood draws, history and physical) the paclitaxel will be administered as a 3-hour infusion immediately followed by a 1-hour infusion of carboplatin per standard of care. The IGFBP-2 study vaccine will be administered 2 weeks after each cycle of chemotherapy.
  • A total of 3 chemotherapy cycles and vaccines will be completed prior to surgery.

On-Site Study Visits

  • The IGFBP-2 trial drug will be administered intradermally (under the skin) at the University of Washington Medical Center. The carboplatin and paclitaxel will be administered per standard of care at the patient’s own oncology clinic.
  • Post vaccine follow-up visits will be conducted at approximately 1-2 weeks and 6 months following the final vaccination.

Long-Term Follow-up

  • Information on how the patient is doing will be obtained from the patient’s primary oncologist once a year for 5 years.

Other Procedures During Study Visits

  • History and physical exam
  • Tetanus vaccine at the first visit only
  • Clinical blood tests plus research blood collection for immune monitoring

Study Location:

University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195

ClinicalTrials.gov Identifier: NCT03029611

Contact Information:
866-932-8588

Email

trialtvg@uw.edu

Clinical Trials Contact

For more information regarding our trials, please call our Patient Coordinator

866-932-8588
Email