Official Title
A Phase 2 Study of Pembrolizumab (MK-3475), DPX-Survivac Vaccine and Low Dose of Cyclophosphamide Combination in Patients With Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer
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-tumour
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.
Trial Description
Primary Outcome:
- Overall response rate (ORR)
Secondary Outcome:
- Progression free survival (PFS) rate
- Overall survival (OS) rate
- Number of side effects
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.
View this trial on ClinicalTrials.gov
