αDC1 Vaccine + Pembrolizumab for Ovarian Cancer

KM
LM
Overseen ByLucia M Borrasso, RN, BSN
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Kalinski, Pawel, MD, PhD
Must be taking: Celecoxib
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments to boost the immune system's response against advanced ovarian cancer. The study adds a vaccine, called αDC1, and a drug called pembrolizumab (an immunotherapy) to a treatment plan that already includes chemotherapy. Participants will also take celecoxib, a common anti-inflammatory medication. This trial may suit women diagnosed with advanced-stage ovarian, tubal, or peritoneal cancer who have not yet received chemotherapy and can undergo surgery.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in cancer therapy.

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

Research has shown that the treatments in this trial, which include a mix of drugs and a vaccine, have shown promise in earlier studies. For example, a combination of rintatolimod, pembrolizumab, and cisplatin achieved a 50% success rate in treating ovarian cancer patients, with some remaining disease-free for over 70 months. However, some side effects were reported.

The αDC1 vaccine, added to the treatment plan, is considered safe based on previous research. It has been used with pembrolizumab in other trials without major safety concerns. Pembrolizumab, when combined with paclitaxel, is already FDA-approved for certain ovarian cancers and is known to extend patient survival, suggesting that this combination is generally well-tolerated.

Celecoxib, a COX2 inhibitor, enhances the effectiveness of paclitaxel and is commonly used for pain and inflammation, providing additional safety reassurance.

Overall, while side effects exist, these treatments have been used in other settings and are generally tolerable for many patients. Individual experiences can vary, so discussing with a healthcare provider is important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of αDC1 Vaccine and Pembrolizumab for ovarian cancer because these treatments uniquely harness the power of the immune system to fight cancer. Unlike current standard treatments such as surgery and chemotherapy, which directly target cancer cells, Pembrolizumab is an immunotherapy that works by blocking a protein called PD-1, helping the immune system recognize and attack cancer cells more effectively. The αDC1 Vaccine is designed to boost the immune system further by training it to better identify ovarian cancer cells. Together, these therapies offer a promising new approach that could enhance the body's natural ability to combat cancer, potentially leading to more effective and sustainable outcomes.

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

Research has shown that the combination of treatments in this trial, including paclitaxel, cisplatin, rintatolimod, and pembrolizumab, holds promise for treating ovarian cancer. Participants may receive these treatments, with a previous study finding that 50% of patients responded and 79% experienced some clinical benefit—encouraging results for those with advanced ovarian cancer. Celecoxib, a drug that reduces inflammation, is also part of the treatment and has been shown to enhance paclitaxel's effectiveness by increasing cancer cell death. Additionally, pembrolizumab has improved survival rates when combined with chemotherapy for ovarian cancer. The αDC1 vaccine, included in one of the treatment arms, is under study for its potential to strengthen the immune system's fight against cancer cells. These findings suggest better outcomes for patients with advanced ovarian cancer.13456

Who Is on the Research Team?

RE

Robert Edwards, MD

Principal Investigator

UPMC Magee Womens Hospital

Are You a Good Fit for This Trial?

This trial is for adults with advanced stage (III-IV) ovarian, fallopian tube, or peritoneal cancer who have not had chemotherapy before. Participants must be healthy enough for surgery and chemotherapy, have measurable disease, and agree to use effective birth control during the study.

Inclusion Criteria

I am willing to have a blood cell collection procedure (leukapheresis).
Patients must be willing to adhere to protocol requirements
My liver function tests are within the acceptable range.
See 14 more

Exclusion Criteria

I have not had another invasive cancer in the past five years.
My tumor is low risk or I do not have cancer in my abdomen.
I do not have any serious uncontrolled diseases besides cancer.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intensive locoregional chemoimmunotherapy, intradermal autologous αDC1 vaccines, and systemic pembrolizumab

Up to 2 months
Multiple cycles of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 14 months

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival

Up to 7 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bioferon (Interferon-alpha)
  • Celecoxib
  • Cisplatin
  • Debulking Procedure
  • Paclitaxel
  • Pembrolizumab
  • Rintatolimod
  • αDC1 Vaccine

Trial Overview

The trial is testing a combination of treatments: chemo drugs (cisplatin, paclitaxel), immune therapies (αDC1 vaccine, pembrolizumab/Keytruda), rintatolimod, interferon-alpha, celecoxib, and surgery. All patients receive these in a set sequence to see if this approach helps fight advanced ovarian cancer.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Safety Lead-in: Paclitaxel + Cisplatin + Bioferon + Rintatolimod + Pembrolizomab + CelecoxibExperimental Treatment7 Interventions
Group II: Paclitaxel + Cisplatin + Bioferon + Rintatolimod + DC1 Vaccine + Pembrolizomab + CelecoxibExperimental Treatment8 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kalinski, Pawel, MD, PhD

Lead Sponsor

Northwest Biotherapeutics

Industry Sponsor

Trials
8
Recruited
470+

AIM ImmunoTech Inc.

Industry Sponsor

Trials
15
Recruited
710+

Citations

Study Details | NCT07634094 | Intensive Locoregional ...

This trial proposes to evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal ...

Rintatolimod-Based Regimen Hits 50% Response Rate in ...

The clinical benefit rate reached 79%. Median overall survival was 32.5 months, with select patients achieving durable responses exceeding 70 ...

αDC1 Vaccine + Pembrolizumab for Ovarian Cancer

The trial is testing a combination of treatments: chemo drugs (cisplatin, paclitaxel), immune therapies (αDC1 vaccine, pembrolizumab/Keytruda), rintatolimod, ...

The safety, efficacy, and treatment outcomes of a combination ...

Results: Disease control rate (DCR) and objective response rate (ORR) were 73.91% and 23.91% in disease measurable patients by RECIST criteria, totally 76.92% ...

Cost-effectiveness of pembrolizumab plus weekly ...

Conclusion: Compared with placebo plus weekly paclitaxel, pembrolizumab plus weekly paclitaxel improved survival and QALYs in patients with PD-L1–positive ...

Rintatolimod Plus Pembrolizumab and Cisplatin Displays ...

Patients experienced durable responses, with some remaining disease-free for more than 70 months; median overall survival reached 32.5 months.