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Ovarian CancerPhase 2NCT07634094

Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer

A Phase 2 study testing Paclitaxel, Cisplatin and Bioferon in people with Ovarian Cancer, run by Kalinski, Pawel, MD, PhD at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This trial proposes to evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Paclitaxel, Cisplatin and Bioferon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
Oct 2026to Aug 2029
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have advanced stage (III-IV) epithelial carcinoma or carcinosarcoma of ovarian, tubal or peritoneal origin.
  • Histologic documentation of the original primary tumor is required via a pathology report.
  • Patients must be eligible for cancer-related definitive therapy with neoadjuvant chemotherapy.
  • Patients must be chemo-naive and receiving therapy in primary first-line neoadjuvant setting.
  • Patients must have ECOG performance of 0-1.
  • Patients must be reasonable candidate for interval debulking surgery as well as for IP platinum-based combination chemotherapy regimen, with no prior evidence of clinically significant intra-abdominal adhesions, persistent abdominal wall infections, renal disease or bowel obstruction.
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  • At least one lesion must be considered to be large enough for biopsy and resection to yield greater than 2 grams of tumor for tumor loading of αDC1's and immunoassays at the discretion of the treating investigator and/or surgeon.
  • Patients must have measurable disease per iRECIST criteria.
  • Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.
  • Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:
  • Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
  • Patients must be willing to undergo leukapheresis.
  • Patients must be willing to adhere to protocol requirements.
  • Patients must have adequate:
  • Bone marrow function:
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/μL
  • Platelets greater than or equal to 100,000/μL
  • Hemoglobin greater than or equal to 8.0 g/dL
  • Renal function:
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
  • Hepatic function:
  • Bilirubin less than or equal to 1.5 x ULN
  • SGOT and alkaline phosphatase less than or equal to 2.5 x ULN
  • Patients who have signed informed consent and authorization permitting release of personal health information.
  • Patients must be ≥ 18 years of age.
  • Patient must be able to swallow oral medication and have no absorption related medical concern as deemed by the investigator.

Who cannot join

  • Patients with sarcoma.
  • Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis).
  • Patients with a known allergy to cisplatin or taxane chemotherapy. Patients with carboplatin allergy may be included if they tolerate a test dose of IV cisplatin given in monitored floor conditions. Patients who are allergic to paclitaxel can be alternatively treated with abraxane.
  • Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids.
  • Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.
  • Patients with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies.
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  • Patients with uncontrolled diseases other than cancer will be excluded.
  • Patients who have contraindications to the use of NSAID's like chronic renal failure, coronary artery disease, or bleeding ulcers.
  • Patients who have contraindications to the use of interferon α-2b (Bioferon), including hypersensitivity to interferon-α or any component of the product, autoimmune hepatitis, and decompensated liver disease.
  • Patients with tumors of low malignant potential, except ovarian pseudomyxoma or with no peritoneal disease.
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
  • Patients with previous pelvic radiation therapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kelsey Mitch, RN, BSN contact

4126412357

adamikka2@upmc.edu

Lucia M Borrasso, RN, BSN contact

4126413304

borrlm@upmc.edu

United States1 site

  • UMPC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Kelsey Mitch, 4126412357, adamikka2@upmc.edu

    Lucia M Borrasso, 4126413304, borrlm@upmc.edu

Other trials in United States

About this study

Official title: A Phase 2 Efficacy Trial of Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer

This trial proposes to evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced stage ovarian cancer (III-IV) in the primary neoadjuvant setting. It was previously determined the tolerable dose of IPC-CKM. This study will add intradermal (ID) autologous αDC1 vaccines (known to be nontoxic) to the tolerable IPC-CKM regimen and systemic Keytruda (pembrolizumab). To optimize the pattern of immunity, all patients will also receive oral celecoxib (COX2 inhibitor).

Read the detailed description

In addition to its typically late detection, the difficulty in treating OvCa results from its particular adeptness at avoiding immune elimination. Several vaccine trials targeting ovarian cancer have recently reported a lack of efficacy with vaccine only approaches. OvCa cells have been reported to display numerous defects in their MHC class I antigen-presenting capacity, involving loss of HLA alleles and loss of the molecules involved in the generation of antigenic peptides. In addition to these passive mechanisms of immune subversion, OvCa employs a series of active suppressive mechanisms, involving the suppression of endogenous immune cells and innate immune response pathways, and a particularly high ability to attract regulatory T cells (Tregs), mediated by elevated expression of CXCL12 and CCL22 2. It is suspected that massive chemotherapy-induced apoptosis may further promote this modulation by enhancing local immunity. These considerations suggest that effective immunotherapies of OvCa may need to involve countermeasures to both these modes (passive and active) of immune subversion. Since αDC1-induced CD8+ T cells express particularly high levels of the typical CTL-associated chemokine receptors (CXCR3 and CCR5), the therapeutic benefit of αDC1 vaccination is likely to be enhanced by the CKM therapies, able of selectively enhancing CXCL10 (and other CXCR3 ligands) as well as CCR5 ligands, such as CCL5/RANTES, in order to promote the entry of the vaccination-induced effector cells to tumor tissue.

Conditions
Ovarian Cancer
Being tested
Paclitaxel, Cisplatin, Bioferon, Rintatolimod, αDC1 Vaccine
Keywords
myeloid-suppressor cell (MDSC), T regulatory cells, COX2 inhibitor, Autologous Alpha-DC1 Vaccine
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol, taxane

    A chemotherapy for cancer patients that interferes structures that help move chromosomes during cell division, thus stabilizing these structures to prevents cancer cells from dividing and ultimately causing them to die.

    Dose: 175 mg/m^2 IV on D1 each cycle during neoadjuvant and adjuvant periods.

  • CisplatinDrug

    Also called Platinol®

    An alkylating agent that contains platinum, which binds to DNA in cancer cells, causing cross-links that prevent DNA replication and repair, leading to cell death, particularly in rapidly dividing cancer cells.

    Dose: 75 mg/m^2 IP / 1 hour on D1 of each cycle during neoadjuvant and adjuvant treatment periods.

  • BioferonDrug

    Also called (Interferon Alfa)-2a

    Inhibits replication of a wide range of RNA and DNA viruses and exerts antiproliferative effects on malignant cells. It suppresses antibody formation through an effect on B-lymphocytes and inhibits onset of delayed hypersensitivity.

    Dose:6 milli on units/100 mL IP over 30-60 minutes on D2 of each cycle during neoadjuvant and adjuvant treatment. D1 during maintenance treatment periods.

  • RintatolimodDrug

    Also called Ampligen®

    A synthetic double-stranded RNA that selectively activates Toll-like Receptor 3 (TLR3), triggering antiviral and immunomodulatory responses, priming the immune system without causing excessive inflammation.

    Dose: 200 mg IP over 1-2 hours on D2 of each cycle during the neoadjuvant and adjuvant treatment periods. D1 during maintenance treatment periods

  • αDC1 VaccineBiological

    Autologous tumor-loaded alpha-DC1 vaccine is the new type of dendritic cell vaccine developed by our group, are the serum-free, clinically-applicable version of type-1 polarized DCs, combining a fully-mature phenotype and high expression of co-stimulatory molecules with an elevated, rather than exhausted, ability to produce IL-12p70.

    Dose: 6 million dendritic cells (reduced or omitted if insufficient vaccine material), ID injection on rotating sides of lower extremities on D2 each cycle during the neoadjuvant (not C1) and adjuvant treatment periods. D1 of each cycle during maintenance period.

  • PembrolizumabDrug

    Also called Keytruda®

    Humanized monoclonal antibody and a PD-1 inhibitor used in cancer immunotherapy that differs from chemotherapy as it does not directly kill cancer cells but stimulates the immune system, particularly T-cells, to recognize and attack cancer cells more effectively.

    Dose: 200 mg IV / 30 minutes on D2 of each cycle during neoadjuvant treatment period (none last neoadjuvant cycle), then optional on D2 for adjuvant treatment cycles, and on D1 of maintenance cycles

  • CelecoxibDrug

    Also called Celebrex®

    A COX-2 inhibitor in the class of nonsteroidal anti-inflammatory drugs (NSAIDs) that specifically target the cyclooxygenase-2 (COX-2) enzyme, which plays a key role in inflammation Dose: 200mg/day, orally twice a day for days 1-5 and once a day for days 6-21 of neoadjuvant and adjuvant treatment cycles, and then twice a day on D1 and once a day for days 2-21 for maintenance cycles

  • Debulking ProcedureProcedure or surgery

    Also called cytoreductive surgery

    A surgical procedure designed to remove the majority of cancerous tumors when complete removal may not be feasible, with the goal of reducing tumor burden, making follow-up treatments like chemotherapy or radiation more effective.

    Surgery occurs in between the neoadjuvant and adjuvant treatment periods.

Study groups in NCT07634094
Study groupRoleWhat they receive
Safety Lead-in: Paclitaxel + Cisplatin + Bioferon + Rintatolimod + Pembrolizomab + CelecoxibExperimentalNot described
Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Bioferon; Drug: Rintatolimod; Drug: Pembrolizumab; Drug: Celecoxib; Procedure: Debulking Procedure
Paclitaxel + Cisplatin + Bioferon + Rintatolimod + DC1 Vaccine + Pembrolizomab + CelecoxibExperimentalNot described
Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Bioferon; Drug: Rintatolimod; Biological: αDC1 Vaccine; Drug: Pembrolizumab; Drug: Celecoxib; Procedure: Debulking Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities (DLT)

    Proportion of patients in the safety cohort (chemoimmunotherapy combined with the αDC1 vaccine) experiencing a dose-limiting toxicity (DLT). A DLT will be any adverse event that is at least possibly related to the study treatment and prevents surgery or delays surgery by more than 4 weeks, or that prevents the initiation of the next cycle of treatment on schedule due to toxicity in the prior cycle. The DLT period will be 2 cycles of treatment.

    Measured: Up to 2 months

  2. Complete Pathologic Response (pCR)

    Percentage of patients who show no detectable cancer (cells) in tissue samples after neoadjuvant treatment as assessed at the time of the interval debulking procedure. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in SLD compared to baseline, confirmed on a follow-up scan.

    Measured: Up to 5 years

Secondary outcomes (5)

  1. Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of patients who experience Adverse Events (AEs) and Serious Adverse Events (SAEs) least possibly related to treatment per CTCAE v 5.0.

    Measured: Up to 14 months

  2. 12-month Progression-free Survival (PFS)

    Percentage of patients without disease progression per iRECIST at 12 months post treatment initiation. Per iRECIST, Progressive Disease (PD): At least a 20% increase in SLD from the nadir, with an absolute increase of ≥5 mm, or the appearance of any new lesion.

    Measured: At 12 months

  3. 18-month Progression-free Survival (PFS)

    Percentage of patients without disease progression per iRECIST at 18 months post treatment initiation. Per iRECIST, Progressive Disease (PD): At least a 20% increase in SLD from the nadir, with an absolute increase of ≥5 mm, or the appearance of any new lesion.

    Measured: At 18 months

  4. Progression-free Survival (PFS)

    Median time from treatment initiation when 50% of patients have disease progression (per RECIST v1.1) or have died from any cause, whichever occurs first. Per RECIST v1.1, Progressive Disease (PD): At least a 20% increase in SLD from the nadir, with an absolute increase of ≥5 mm, or the appearance of any new lesion

    Measured: Up to 5 years

  5. Overall Survival (OS)

    Median time from treatment initiation when 50% of patients have died from any cause.

    Measured: Up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Model description
All drugs will be dosed on a 21-day cycle. The study will consist of 3-4 neoadjuvant treatment cycles, 2-4 adjuvant treatment cycles, and 8 optional maintenance treatment cycles, for a total of 5-16 treatment cycles. An interval debulking procedure will occur in between the neoadjuvant and adjuvant periods of study treatment. The optional maintenance treatment cycles may be included depending on available resources and the clinical opinion of the treating investigator and/or principal investigator. There is the possibility that not all drugs in the maintenance regimen will be administered (e.g. one or more drugs may be omitted, or maintenance cycles may be omitted all together). No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the subject's malignancy.
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07634094
Sponsor's protocol ID
HCC 25-166
Status last verified
Jun 2026
First submitted
2 Jun 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Cisplatin and Bioferon in people with Ovarian Cancer, run by Kalinski, Pawel, MD, PhD at 1 site in United States.

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 26 inclusion and 12 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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Contact Kelsey Mitch, RN, BSN (4126412357, adamikka2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLT) (time frame: Up to 2 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?

On the ClinicalTrials.gov record for NCT07634094.

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 Oct 2026.

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