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Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

ConditionsFallopian Tube CarcinosarcomaPrimary Peritoneal CarcinosarcomaRecurrent Fallopian Tube CarcinomaRecurrent Fallopian Tube Clear Cell AdenocarcinomaRecurrent Fallopian Tube Endometrioid AdenocarcinomaRecurrent Fallopian Tube High Grade Serous AdenocarcinomaRecurrent Ovarian CarcinomaRecurrent Ovarian CarcinosarcomaRecurrent Ovarian Clear Cell AdenocarcinomaRecurrent Ovarian Endometrioid AdenocarcinomaRecurrent Ovarian High Grade Serous AdenocarcinomaRecurrent Primary Peritoneal CarcinomaRecurrent Primary Peritoneal Clear Cell AdenocarcinomaRecurrent Primary Peritoneal Endometrioid AdenocarcinomaRecurrent Primary Peritoneal High Grade Serous AdenocarcinomaRecurrent Primary Peritoneal Carcinosarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

This phase I/II trial tests the safety, side effects, best dose, and effectiveness of multi-epitope folate receptor alpha-loaded dendritic cell vaccine (FRalphaDC) with pembrolizumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer (collectively known as ovarian cancer) that that has come back (after a period of improvement) (recurrent). Ovarian cancer is the most lethal gynecologic malignancy in the United States. While the majority of patients achieve a remission from ovarian cancer with the combination of aggressive cytoreductive surgery and cytotoxic chemotherapy, over 80% of patients develop recurrence within 3 years of completion of treatment. Additional treatments are needed for recurrence, but the standard treatment modalities are non-curative in nature due to the development of drug resistance. As such, there is a great unmet need for treatment strategies that utilize new mechanisms to which drug resistance does not develop. FRalphaDC is a dendritic cell vaccine that is made from the white blood cells collected from a procedure call apheresis. The white blood cells are treated to make dendritic cells, which will then be incubated with peptides, which are pieces of a protein known as "folate receptor alpha" (FRalpha), a protein that is found in high levels on ovarian cancer cells. Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the tumor cells by targeting the FRalpha protein. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving FRalphaDC vaccine with pembrolizumab may be a safe and effective treatment for recurrent ovarian cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years

Histologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer NOTE: Histologic confirmation of the primary tumor or recurrent tumor per pathology report is required. Eligible histotypes include high grade serous; endometrioid; and clear cell carcinoma, as these histotypes have high expression of FRalpha. Mixed carcinomas, including carcinosarcomas, with >= 50% of the tumor comprised of high grade serous; and/or endometrioid; and/or clear cell carcinoma are eligible

Ovarian cancer (OC) recurrence - Platinum sensitivity/resistance

Platinum-refractory (defined as recurrence or progression of OC =< 30 days of the last dose of platinum-based chemotherapy)

Disqualifiers

Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown

Pregnant persons

Nursing persons

Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine

    Biological/Vaccine

    Given ID

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Pheresis

    Procedure/Surgery

    Undergo apheresis

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Treatment (apheresis, FRalphaDC, pembrolizumab)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Determine whether the combination of FRαDCs and pembrolizumab has an acceptable toxicity profile.

Three patients will be enrolled to starting dose (dose level 1) and enrollment will pause until each of the first 3 patients have completed cycle 1 of therapy. If zero or one of first 3 patients develops a dose limiting toxicity (DLT) during cycle 1, 3 more patients will be enrolled to dose level 1. If observe at most 1 DLT in the first 6 patients at dose level 1, it will be considered safe and will continue in phase II of trial. If 2 or more of the first 6 patients develop a DLT during cycle 1 for dose level 1, then enrollment will stop and dose level will be decreased. Additional patients will be enrolled in cohorts of 3 to that decreased dose level. If zero or one DLT in the first 6 patients at dose level -1, it will be considered safe and will continue in phase II of trial. Otherwise, if observe 2 or more DLTs in the first 6 patients of dose level -1, enrollment will stop until the Study Team adjusts the treatment plan with input from the Data Safety Monitoring Board.

Time frame
Up to 21 days
2

Confirm objective response rate (ORR)

Defined as the proportion of patients with a complete response (CR) or partial response (PR). If at least 7 confirmed responses are observed in the first 32 eligible patients (22%), the combination treatment will be considered worthy of further investigation.

Time frame
Up to 5 years

Secondary outcomes

1

Disease control rate

Defined as the proportion of patients with a complete response (CR),partial response (PR), or stable disease.

Time frame
Up to 5 years
2

Duration of response

Duration of response (DoR) is defined as the time from the first disease assessment showing a complete response (CR) or partial response (PR) until the date of either disease progression or death of any cause.

Time frame
Up to 5 years
3

Progression free survival (PFS)

PFS will be estimated using the Kaplan-Meier method. The date of progression will be the date on which progressive disease is first detected, even if the patient does not immediately come off study.

Time frame
Up to 5 years
4

Overall survival (OS)

OS will be estimated using the Kaplan-Meier method. OS is defined as the time from study entry to death from any cause.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

NanoPass Technologies Ltd

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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