Platinum-resistant Epithelial Ovarian CancerPhase 2AVALONNCT05243524
Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer
A Phase 2 study testing Maveropepimut-S and Cyclophosphamide 50mg in people with Platinum-resistant Epithelial Ovarian Cancer, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 6 sites in 3 countries.
Trial summary
Phase 2, single arm, study to assess the efficacy and safety of maveropepimut-S (MVP-S) and low-dose cyclophosphamide (CPA) in subjects with recurrent, platinum resistant ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum-resistant Epithelial Ovarian Cancer
- What is being tested?
- Maveropepimut-S and Cyclophosphamide 50mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 5 Aug 2022to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, histologically diagnosed high-grade serous
- Platinum-resistant disease (relapsing within 3-6 months after completion of initial platinum-based treatment). Patients progressing at any time on or after ≥ 2nd platinum-based therapy are eligible.
- Received ≤ 4 prior lines of anti-cancer therapy for ovarian cancer, including at least one platinum-based therapy
- Evidence of progressive disease
- Measurable disease (RECIST v1.1) with at least one non-target lesion accessible by image-guided biopsy. No single lesion may be larger than 4 cm in diameter.
- Completed pre-treatment tumor biopsy and willing to undergo on-treatment tumor biopsy
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- ECOG 0-1
- Live expectancy ≥ 6 months
- Meet protocol-specified laboratory requirements
Who cannot join
- Concurrent chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or radiotherapy
- Prior receipt of survivin-based vaccines/therapy, immune checkpoint inhibitors, IDO inhibitor, or cell-based therapy
- Non-epithelial tumor origin of the ovary, fallopian tube, or peritoneum
- Clinical ascites
- Concurrent second malignancy other than basal or squamous cell skin cancer, cervical carcinoma in situ, or Stage I or II caner in complete remission
- GI condition that might limit absorption of oral agents
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- Recent history of thyroiditis
- History of autoimmune disease requiring treatment within the last two years (except paraneoplastic syndrome, vitiligo, or diabetes)
- History of bowel obstruction related to the disease
- Presence of a serious acute infection or chronic infection
- Uncontrolled concurrent illness or history of significant cardiac or pulmonary disfunction
- Myocardial infarction or cerebrovascular event within past 6 months
- Known central nervous system (CNS) or leptomeningeal metastasis (brain metastases)
- Clinically significant illness or major surgery within past 28 days or anticipated need for major surgery during study treatment
- Ongoing treatment with steroid therapy or other immunosuppressive
- Receipt of live attenuated vaccines
- Edema or lymphedema in the lower limbs > grade 2
- Acute or chronic skin and/or microvascular disorders
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
NYU Langone Hospital-Long Island
Mineola, New York, 11501
NYU Langone: Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
Ocala Oncology
Ocala, Florida, 34474
Stanford Health Care
Palo Alto, California, 94305
Canada1 site
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
About this study
Official title: Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer.
Phase 2, single arm, study to assess the efficacy and safety of maveropepimut-S (MVP-S) and low-dose cyclophosphamide (CPA) in subjects with recurrent, platinum resistant ovarian cancer.
Read the detailed description
A Simon two-stage statistical design to assess MVP-S in combination with low dose CPA in platinum-resistant epithelial ovarian cancer patients who have received no greater than 4 previous lines of anti-cancer therapy.
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).
- Being tested
- Maveropepimut-S, Cyclophosphamide 50mg
- Keywords
- T cell education, DPX-Survivac, Immunotherapy, Platinum-resistant (PROC), High grade serous (HGSOC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maveropepimut-SOther
Also called MVP-S, DPX-Survivac
SC injection on days 7, 28, then q8w
Cyclophosphamide 50mgDrug
Also called CPA, Procytox, Cytoxan
PO BID, one week on, one week off
| Study group | Role | What they receive |
|---|---|---|
| MVP-S + CPA | Experimental | All subjects will receive two doses of maveropepimut-S (q3w) followed by up to six doses (q8w) plus low-dose cyclophosphamide on a repeating cycle of one week on/one week off. Receives: Other: Maveropepimut-S; Drug: Cyclophosphamide 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
per RECIST v1.1 criteria
Measured: up to 13 months
Secondary outcomes (9)
Objective Response Rate (ORR)
per iRECIST criteria
Measured: up to 13 months
Duration of Response (DOR)
Measured: up to 23 months
Disease Control Rate (DCR)
Measured: up to 13 months
Time to Progression (TTP)
Measured: up to 23 months
Progression Free Survival (PFS)
Measured: up to 23 months
Progression Free Survival (6m PFS)
Measured: at 6 months
Overall Survival (OS)
Measured: up to 23 months
CA-125 Response
monthly measurements
Measured: up to 13 months
Frequency of adverse events
graded using NCI CTCAE v5.0
Measured: up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start5 Aug 2022
- Primary completion24 Jul 2023
- Study completion31 Aug 2023
Why it stopped: Closure of IMV operations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-resistant Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243524
- Sponsor's protocol ID
- P1606-SUR-O25
- Acronym
- AVALON
- Status last verified
- Sep 2023
- First submitted
- 7 Feb 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT05243524
- Acronym / sponsor ID
- AVALON / P1606-SUR-O25
- Keywords
- T cell education, DPX-Survivac, Immunotherapy, Platinum-resistant (PROC), High grade serous (HGSOC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closure of IMV operations
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2, single arm, study to assess the efficacy and safety of maveropepimut-S (MVP-S) and low-dose cyclophosphamide (CPA) in subjects with recurrent, platinum resistant ovarian cancer.
Detailed description
A Simon two-stage statistical design to assess MVP-S in combination with low dose CPA in platinum-resistant epithelial ovarian cancer patients who have received no greater than 4 previous lines of anti-cancer therapy.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MVP-S + CPA | Experimental | Other: Maveropepimut-S, Drug: Cyclophosphamide 50mgAll subjects will receive two doses of maveropepimut-S (q3w) followed by up to six doses (q8w) plus low-dose cyclophosphamide on a repeating cycle of one week on/one week off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, histologically diagnosed high-grade serous
- Platinum-resistant disease (relapsing within 3-6 months after completion of initial platinum-based treatment). Patients progressing at any time on or after ≥ 2nd platinum-based therapy are eligible.
- Received ≤ 4 prior lines of anti-cancer therapy for ovarian cancer, including at least one platinum-based therapy
- Evidence of progressive disease
- Measurable disease (RECIST v1.1) with at least one non-target lesion accessible by image-guided biopsy. No single lesion may be larger than 4 cm in diameter.
Key exclusion criteria (18 listed)
- Concurrent chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or radiotherapy
- Prior receipt of survivin-based vaccines/therapy, immune checkpoint inhibitors, IDO inhibitor, or cell-based therapy
- Non-epithelial tumor origin of the ovary, fallopian tube, or peritoneum
- Clinical ascites
- Concurrent second malignancy other than basal or squamous cell skin cancer, cervical carcinoma in situ, or Stage I or II caner in complete remission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maveropepimut-SAlso: MVP-S, DPX-SurvivacSC injection on days 7, 28, then q8w | Other | MVP-S + CPA |
| Cyclophosphamide 50mgAlso: CPA, Procytox, CytoxanPO BID, one week on, one week off | Drug | MVP-S + CPA |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 13 months
per RECIST v1.1 criteria
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 13 months
Duration of Response (DOR)
Time frame: up to 23 months
Disease Control Rate (DCR)
Time frame: up to 13 months
Time to Progression (TTP)
Time frame: up to 23 months
Progression Free Survival (PFS)
Time frame: up to 23 months
Progression Free Survival (6m PFS)
Time frame: at 6 months
Overall Survival (OS)
Time frame: up to 23 months
CA-125 Response
Time frame: up to 13 months
Frequency of adverse events
Time frame: up to 13 months
Results and safety
The study was stopped early (reason given: Closure of IMV operations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maveropepimut-S and Cyclophosphamide 50mg in people with Platinum-resistant Epithelial Ovarian Cancer, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Closure of IMV operations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.