Immunotherapy for Ovarian Cancer

Not currently recruiting at 9 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

Must not be taking: Steroids, Immunosuppressives, MAOIs, others

Disqualifiers: Autoimmune, CNS metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments to determine if they can safely activate the immune system to combat recurrent ovarian, fallopian tube, or peritoneal cancer. The treatments under study include DPX-Survivac (an immunotherapy), cyclophosphamide, and epacadostat, which together aim to enhance the body's natural defenses against cancer. Individuals with ovarian cancer that has progressed after standard treatments and who maintain daily activity might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on steroid therapy, immunosuppressives, MAOIs, UGT1A9 inhibitors, and those who have received live vaccines. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DPX-Survivac, combined with a low dose of cyclophosphamide, is generally easy for patients to handle. Studies have found that this combination helps patients with recurring ovarian cancer by triggering a strong immune response against tumors, which is promising.

Regarding epacadostat, research indicates it is also mostly easy for patients to tolerate. Most side effects were mild and manageable, and patients with ovarian cancer did not report any serious side effects from using epacadostat alone.

These findings suggest that the treatments in this trial are safe for humans based on previous studies. However, discussing any concerns with the trial team remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about DPX-Survivac for ovarian cancer because it uses an innovative approach known as immunotherapy. Unlike traditional treatments like chemotherapy, which directly attack cancer cells, DPX-Survivac works by stimulating the body's immune system to recognize and fight the cancer. This treatment targets a protein called survivin, which is often overexpressed in cancer cells, potentially leading to more precise and effective elimination of tumors. Additionally, in combination with drugs like Cyclophosphamide and Epacadostat, DPX-Survivac may enhance the overall immune response, offering a promising new avenue for patients with ovarian cancer.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Research has shown that DPX-Survivac, one of the treatments in this trial, may effectively treat recurrent ovarian cancer. Studies found that patients lived an average of 19.9 months, with about 44.9% surviving nearly two years, indicating a strong potential benefit for this condition. In this trial, some participants will receive DPX-Survivac combined with Cyclophosphamide and Epacadostat, while others will receive DPX-Survivac with Cyclophosphamide only. Past studies have shown that Epacadostat, intended to help the immune system fight cancer, has not been more effective than standard treatments. It is generally well-tolerated, but its impact when used alone has been limited. Together, these treatments aim to enhance the immune system's response against cancer. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with recurrent ovarian, fallopian tube, or peritoneal cancer who have completed first-line treatment and may have had subsequent chemotherapy. They should be able to perform daily activities (ECOG 0-1), have a life expectancy of at least 6 months, measurable disease, and no history of certain autoimmune diseases or other serious conditions.

Inclusion Criteria

You meet the specific lab test requirements outlined in the study.

My cancer is getting worse, shown by tests or scans.

My cancer can be measured and I agree to have tumor biopsies before and during treatment.

Exclusion Criteria

I have not received vaccines or drugs targeting immune checkpoints or IDO inhibitors.

I have received a live vaccine recently.

I have a skin or blood vessel disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Participants receive DPX-Survivac, low dose cyclophosphamide, and epacadostat to determine the recommended Phase 2 dose

Duration not specified

Phase 2 Treatment

Participants receive DPX-Survivac and cyclophosphamide, with or without epacadostat, to evaluate safety and effectiveness

up to 13 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cyclophosphamide
• DPX-Survivac
• Epacadostat (INCB024360)

Trial Overview The study tests the combination of DPX-Survivac therapy with low dose oral cyclophosphamide and IDO1 inhibitor epacadostat in patients. It aims to assess safety and how well these treatments can modulate the immune system against cancer cells.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 2 Interventions

DPX-Survivac, Cyclophosphamide (in Phase 2 only)

Group II: Arm 1 Experimental Treatment 3 Interventions

DPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)

DPX-Survivac is already approved in United States, European Union, Canada for the following indications:

Approved in United States as DPX-Survivac for:

• None approved yet; under investigation for various cancers including ovarian cancer and diffuse large B-cell lymphoma

Approved in European Union as DPX-Survivac for:

• None approved yet; under investigation for various cancers including ovarian cancer and diffuse large B-cell lymphoma

Approved in Canada as DPX-Survivac for:

• None approved yet; under investigation for various cancers including ovarian cancer and diffuse large B-cell lymphoma

Who Is Running the Clinical Trial?

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Lead Sponsor

Trials

11

Recruited

580+

Incyte Corporation

Industry Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10390884/

Maveropepimut-S, a DPX-Based Immune-Educating ... Maveropepimut-S with intermittent low-dose cyclophosphamide is well-tolerated, with clinical benefit for patients with recurrent ovarian cancer.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37126016/

Maveropepimut-S, a DPX-based immune-educating ... Maveropepimut-S, a DPX-based immune-educating therapy, shows promising and durable clinical benefit in patients with recurrent ovarian cancer, ...

3. cancernetwork.com cancernetwork.com/view/phase-2-decide1-trial-reports-final-topline-results-on-the-efficacy-of-maverpopepimut-s-in-advanced-recurrent-ovarian-cancer

Phase 2 DeCidE1 Trial Reports Final Topline Results on ... Final topline findings from the trial indicated that the median overall survival (OS) was 19.9 months with an OS rate of 44.9% at 23.8 months.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.5505

Results from phase 1 and expansion cohort of PESCO trial. Conclusions: The combination of MVP-S, low-dose CPA, and Pemb was tolerable and met the efficacy endpoint in the expansion cohort in heavily ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-22-2595/727530/p/Maveropepimut-S-a-DPX-Based-Immune-Educating

Maveropepimut-S, a DPX-Based Immune-Educating Therapy ... Maveropepimut-S, a DPX-based immune-educating therapy, shows promising and durable clinical benefit in patients with recurrent ovarian cancer, a Phase II trial.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05243524

Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients ... MVP-S, previously called DPX-Survivac, was recently evaluated in a small Phase 2 single arm study of ovarian cancer patients known as DeCidE1 (NCT02785250).

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)59420-0/fulltext

Safety and efficacy results of the combination of DPX ... DPX-Survivac is a novel T cell activating therapy that has been shown to elicit a strong and prolonged immune response against tumors expressing survivin and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02785250

NCT02785250 | Study of DPX-Survivac Therapy in Patients ... The Phase 1b component is a multicenter, non-randomized, open label, uncontrolled, safety and effectiveness study to identify the recommended Phase 2 dose (R2PD) ...