Ovarian CancerPhase 2NCT03836352
Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors
A Phase 2 study testing DPX-Survivac, Cyclophosphamide and Pembrolizumab in people with Ovarian Cancer and Hepatocellular Carcinoma, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 23 sites in 2 countries.
Trial summary
This study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide with pembrolizumab in subjects with selected advanced and recurrent solid tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer
- What is being tested?
- DPX-Survivac, Cyclophosphamide and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 21 Dec 2018to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with advanced or metastatic solid tumours who have completed treatment with first line therapy:
- Epithelial ovarian, fallopian tube, or peritoneal cancer
- Hepatocellular carcinoma
- Non-small cell lung cancer
- Urothelial cancer
- Microsatellite instability high solid tumours, other than the above indications
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- Radiologic and/or biochemical evidence of disease progression
- Completion of pre-treatment tumour biopsy
- Must have measurable disease by RECIST v1.1
- Ambulatory with an ECOG 0-1
- Life expectancy ≥ 6 months
- Meet protocol-specified laboratory requirements
Who cannot join
- Chemotherapy or immunotherapy within treatment within 28 days of start of study treatment
- Radiotherapy within treatment within 2 weeks of start of study treatment
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor where subject was discontinued from that treatment due to a Grade 3 or higher immune-related toxicity
- For NSCLC subjects: Known EGFR mutations or ALK rearrangements
- Prior receipt of survivin-based vaccine(s) and/or immunotherapies
- Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
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- Clinical ascites or pleural fluid that cannot be managed
- Malignant bowel obstruction or recent history of bowel obstruction
- For OvCa, subjects with any single lesion greater than 5 cm
- Autoimmune disease requiring treatment within the last two years (except replacement therapy)
- Recent history of thyroiditis
- Any history of (non-infectious) pneumonitis that required steroid therapy or current pneumonitis
- Presence of a serious acute or chronic infection
- Active CNS metastases and/or carcinomatous meningitis
- GI condition that might limit absorption of oral agents
- Allogenic tissue/solid organ transplant
- Other serious intercurrent chronic or acute illness, including myocardial infarction or cerebrovascular event within 6 months
- Ongoing treatment with steroid therapy or other immunosuppressive
- Receipt of live attenuated vaccines
- Acute or chronic skin and/or microvascular disorders
- Edema or lymphedema in the lower limbs > grade 2
- Severe hypersensitivity (≥ Grade 3) to pembrolizumab
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States15 sites
Winship Cancer Institute: The Emory Clinic
Atlanta, Georgia, 30322
Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, 33486
Mary Crowley Cancer Research Center
Dallas, Texas, 75230
MD Anderson
Houston, Texas, 77030
Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center
Los Angeles, California, 90048
James Brown Graham Cancer Center:University of Louisville Hospital
Louisville, Kentucky, 40202
NYU Winthrop Hospital
Mineola, New York, 11501
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505
Comprehensive Hematology and Oncology
St. Petersburg, Florida, 33709
Montefiore Medical Center
The Bronx, New York, 10461
University of Toledo
Toledo, Ohio, 43614
The University of Arizona Cancer Center
Tucson, Arizona, 58724
Canada8 sites
William Osler Health System
Brampton, Ontario, L6R3J7
Juravinski Cancer Center
Hamilton, Ontario, L8V 5C2
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
McGill University Health Center
Montreal, Quebec, H4A 3J1
Southlake Regional Health Center
Newmarket, Ontario, L3Y 2P9
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
CHU de Québec-Université Laval
Québec, Quebec, G1R 2J6
Sunnybrook Research Institute
Toronto, Ontario
About this study
Official title: A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in Combination With Low Dose Cyclophosphamide and Pembrolizumab, in Subjects With Selected Advanced and Recurrent Solid Tumours.
This study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide with pembrolizumab in subjects with selected advanced and recurrent solid tumours.
Read the detailed description
This study is a Phase 2 with safety lead-in study to assess the safety and efficacy of DPX-Survivac, low dose cyclophosphamide, and pembrolizumab combination therapy in subjects with selected advanced and recurrent solid tumours. Two ovarian cancer arms will be recruited and randomized in this study, one with and one without cyclophosphamide. All other cohorts will be single arm, receiving treatment with the triple combination.
Up to 20 subjects, from any cohort, will be enrolled to assess the safety of study treatments before the study moves to the expansion phase. Once the safety lead-in is completed, the five cohorts will be expanded to recruit additional subjects following a Simon two stage design. Enrollment in the ovarian cancer cohort will be randomized 1:1 into two arms.
- Conditions
- Ovarian Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Bladder Cancer, Microsatellite Instability-High
- Being tested
- DPX-Survivac, Cyclophosphamide, Pembrolizumab
- Keywords
- T cell activation, Immunotherapy, Ovarian, Hepatocellular Carcinoma, Non-small Cell Lung, Bladder, Microsatellite Instability-High, Survivin, Anti-PD-1, MK-3475
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPX-SurvivacOther
SubQ injection (q9w)
CyclophosphamideDrug
PO (BID)
PembrolizumabDrug
Also called MK-3475
IV Infusion (q3w)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (All cohorts) | Experimental | DPX-Survivac, Cyclophosphamide, Pembrolizumab Receives: Other: DPX-Survivac; Drug: Cyclophosphamide; Drug: Pembrolizumab |
| Arm 2 (Ovarian cohort only) | Experimental | DPX-Survivac, Pembrolizumab Receives: Other: DPX-Survivac; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as measured by objective response rate
Centrally evaluated using RECIST v1.1
Measured: Approximately 24 months
Safety as measured by the rate of adverse events
Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Approximately 24 months
Secondary outcomes (5)
Objective response rate
Centrally evaluated using iRECIST
Measured: Approximately 24 months
Duration of response
Measured: Approximately 24 months
Disease control rate
Measured: Approximately 24 months
Progression Free Survival
Measured: Approximately 24 months
Overall survival
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start21 Dec 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836352
- Sponsor's protocol ID
- P1719-SUR-Z11
- Other IDs
- Keynote 903
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in Combination With Low Dose Cyclophosphamide and Pembrolizumab, in Subjects With Selected Advanced and Recurrent Solid Tumours.
- ClinicalTrials.gov ID
- NCT03836352
- Acronym / sponsor ID
- P1719-SUR-Z11
- Conditions
- Ovarian Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Bladder Cancer, Microsatellite Instability-High
- Keywords
- T cell activation, Immunotherapy, Ovarian, Hepatocellular Carcinoma, Non-small Cell Lung, Bladder, Microsatellite Instability-High, Survivin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Feb 2019 (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.
This study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide with pembrolizumab in subjects with selected advanced and recurrent solid tumours.
Detailed description
This study is a Phase 2 with safety lead-in study to assess the safety and efficacy of DPX-Survivac, low dose cyclophosphamide, and pembrolizumab combination therapy in subjects with selected advanced and recurrent solid tumours. Two ovarian cancer arms will be recruited and randomized in this study, one with and one without cyclophosphamide. All other cohorts will be single arm, receiving treatment with the triple combination.
Up to 20 subjects, from any cohort, will be enrolled to assess the safety of study treatments before the study moves to the expansion phase. Once the safety lead-in is completed, the five cohorts will be expanded to recruit additional subjects following a Simon two stage design. Enrollment in the ovarian cancer cohort will be randomized 1:1 into two arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (All cohorts) | Experimental | Other: DPX-Survivac, Drug: Cyclophosphamide, Drug: PembrolizumabDPX-Survivac, Cyclophosphamide, Pembrolizumab |
| Arm 2 (Ovarian cohort only) | Experimental | Other: DPX-Survivac, Drug: PembrolizumabDPX-Survivac, Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects with advanced or metastatic solid tumours who have completed treatment with first line therapy:
- Radiologic and/or biochemical evidence of disease progression
- Completion of pre-treatment tumour biopsy
- Must have measurable disease by RECIST v1.1
- Ambulatory with an ECOG 0-1
Key exclusion criteria (22 listed)
- Chemotherapy or immunotherapy within treatment within 28 days of start of study treatment
- Radiotherapy within treatment within 2 weeks of start of study treatment
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor where subject was discontinued from that treatment due to a Grade 3 or higher immune-related toxicity
- For NSCLC subjects: Known EGFR mutations or ALK rearrangements
- Prior receipt of survivin-based vaccine(s) and/or immunotherapies
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 |
|---|---|---|
| DPX-SurvivacSubQ injection (q9w) | Other | Arm 1 (All cohorts), Arm 2 (Ovarian cohort only) |
| CyclophosphamidePO (BID) | Drug | Arm 1 (All cohorts) |
| PembrolizumabAlso: MK-3475IV Infusion (q3w) | Drug | Arm 1 (All cohorts), Arm 2 (Ovarian cohort only) |
Primary outcome
Efficacy as measured by objective response rate
Time frame: Approximately 24 months
Centrally evaluated using RECIST v1.1
Safety as measured by the rate of adverse events
Time frame: Approximately 24 months
Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
5 secondary outcomes
Objective response rate
Time frame: Approximately 24 months
Duration of response
Time frame: Approximately 24 months
Disease control rate
Time frame: Approximately 24 months
Progression Free Survival
Time frame: Approximately 24 months
Overall survival
Time frame: Approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DPX-Survivac, Cyclophosphamide and Pembrolizumab in people with Ovarian Cancer and Hepatocellular Carcinoma, run by ImmunoVaccine Technologies, Inc. (IMV Inc.) at 23 sites in 2 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 12 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Efficacy as measured by objective response rate (time frame: Approximately 24 months). The study lists 2 primary outcomes in all. 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 31 Mar 2022.