Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer

  • STATUS
    Recruiting
  • End date
    Feb 12, 2024
  • participants needed
    42
  • sponsor
    University Health Network, Toronto
Updated on 3 March 2022
cancer
cyclophosphamide
measurable disease
carcinoma
skin cancer
lung cancer
chemotherapy drug
pembrolizumab
cancer chemotherapy
fallopian tube
line of therapy
peritoneal cancer
primary peritoneal carcinoma
tumor debulking
intraperitoneal chemotherapy
dpx-survivac
fallopian tube cancer
interval debulking surgery

Summary

This is a phase 2 study whose purpose is to see whether the combination of of pembrolizumab, DPX-Survivac vaccine and low-dose cyclophosphamide has anti-tumor activity in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.

DPX-Survivac is an investigational vaccine. A vaccine is a substance that is often given to stimulate the body's immune system (the structure and processes in the body that protects against harmful substances) to help prevent against certain diseases. DPX-Survivac is a vaccine that may teach the immune system to recognize cancer cells and to kill them.

Pembrolizumab is a drug that is approved for the treatment of a certain type of melanoma (a type of skin cancer) and non-small cell lung cancer. Pembrolizumab blocks the function of a protein called programmed cell death receptor-1 (PD-1). PD-1 works by keeping the immune system from destroying cancer cells. Stopping PD-1 from working may help the immune system to fight cancer cells.

Cyclophosphamide is chemotherapy drug that is approved for the treatment of various cancers alone and in combination with other drugs.

Description

This study has two phases: a dose escalation phase and a dose expansion phase.

For the dose escalation part, groups of participants will receive one of two dose levels of study drugs to determine the best dose level for further testing.

Once the best dose level is found, additional participant will be enrolled to the dose expansion to further test the safety, tolerability, and efficacy of the study drugs at that dose level in specific types of cancers. All participants will receive pembrolizumab, DPX-Survivac, and low-dose cyclophosphamide.

Participants will be screened for eligibility by standard safety tests and procedures within 28 days of the start of the study drug. Tests and procedures done for research purposes only during this time include archival tumor tissue collection, fresh research biopsy, and blood sample collection for biomarker/genetic/immune research. Participants will also be asked if they agree to an optional fresh research biopsy at disease progression

Eligible participants will receive the following every 21 day cycle:

  • Pembrolizumab, intravenously, at 200 mg, on Day 1 of every cycle.
  • DPX-Survivac, by injection under the skin of the upper thigh in clinic. Participants will receive one priming dose of 0.25 mL of DPX-Survivac on Cycle 1 Day 1. After about 6 weeks, participants will receive an additional boosting dose of 0.25 or 0.5 mL DPX-Survivac depending on the assigned dose level.
  • Cyclophosphamide, orally, at 50 mg, twice a day, starting about 7 days before Cycle 1 Day 1, then continue 7 days off, 7 days on.

While receiving the study treatment, participants will be asked to visit the study site on Day 1 of Cycles 1-8 for tests and procedures. Tests and procedures done for research purposes only include additional blood sample collection and a second fresh research biopsy for biomarker/genetic/immune research.

Participants who benefit from the study treatment may be able to receive additional treatment if they progress after stopping the study treatment.

When participants are taken off the study treatment permanently, they will be asked to return to the study site for an End of Study Treatment visit about 30 days after stopping the study treatment to have tests and procedures done for safety purposes.

Participants who are taken off the study treatment for any reason other than disease progression will continue to have radiological assessments and blood draws every 12 weeks for the first year and every 24 weeks after year 1 until they start a new anti-cancer treatment, disease progression, or the study ends. Participants will continue to be followed for survival and to review any new anti-cancer therapies every 12 weeks.

Details
Condition Advanced Cancer, Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
Treatment cyclophosphamide, Pembrolizumab, DPX-Survivac
Clinical Study IdentifierNCT03029403
SponsorUniversity Health Network, Toronto
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must have histologically or cytologically confirmed advanced epithelial ovarian, primary peritoneal or fallopian tube carcinomas
Patients must have radiologically documented disease progression from their prior line of therapy
Patients must have measurable disease based on RECIST 1.1
Have received a front line platinum-based regimen (administered via either IV or IP) following primary or interval debulking surgery with documented disease recurrence
Have fulfilled the following additional requirements regarding prior treatments depending on the cohort that the patient is to be enrolled in
Eastern Cooperative Group (ECOG) performance status <=1
Life expectancy greater than 16 weeks
Availability of archival tumor tissue samples. Additional samples may be requested if tumor tissue provided is not adequate for quality and/or quantity as assessed by the laboratory
Be willing to provide tumor tissue from a newly obtained core or excisional biopsy prior to start treatment and on day 15 of cycle 1

Exclusion Criteria

Patients who are receiving any other investigational agents
Diagnosis of immunodeficiency or therapy with systemic steroid or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
History of autoimmune disease, such as but not restricted to, rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years. Patients with vitiligo or diabetes are not excluded
Patients with history of thyroiditis within 5 years
Patients with known history of active TB (Bacillus Tuberculosis)
Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Hypersensitivity to Pembrolizumab, DPX-Survivac immunovaccine, Cyclophosphamide or any of their excipients
Patients that have received a live vaccine within 30 days of planned start of study therapy
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or DPX-Survivac vaccine
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note