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Compensation: Varies

Number of Visits: Unknown

Duration: Up to 42 months

68 Participants Needed

Niraparib + Ipilimumab for Pancreatic Cancer
(ParpVax2 Trial)

Recruiting at 1 trial location

Overseen ByKim Reiss Binder, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Abramson Cancer Center at Penn Medicine

Must be taking: FOLFIRINOX, NALIRIFOX

Must not be taking: PARP inhibitors, CTLA-4 inhibitors

Disqualifiers: Autoimmune disease, Hypertension, others

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

Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining the drugs niraparib (a PARP inhibitor) and ipilimumab (an immunotherapy) can slow tumor growth in people with pancreatic cancer. Participants will be randomly assigned to one of two groups: one group will receive the experimental drugs, while the other will receive standard chemotherapy. The trial will also monitor any medical issues arising from niraparib and ipilimumab. Individuals diagnosed with metastatic pancreatic cancer who have previously undergone certain chemotherapy treatments might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received any systemic treatment for pancreatic cancer within 14 days before starting the trial, and you must not be on certain immunosuppressive medications or corticosteroids above a specific dose within 14 days of starting the study treatment.

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

Research has shown that the combination of niraparib and ipilimumab is being tested for safety in treating advanced pancreatic cancer. In earlier studies, patients taking these medications experienced common side effects, including low blood platelet levels, joint pain, nausea, and tiredness.

Despite these side effects, the treatment showed promise in extending the time patients lived without their cancer worsening. While side effects exist, the treatment might still benefit some patients. Discussing these side effects with a doctor is important to understand their implications.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about Niraparib + Ipilimumab because they offer a fresh approach to treating pancreatic cancer. Unlike standard treatments like FOLFIRI, which rely on chemotherapy, Niraparib is a PARP inhibitor that blocks cancer cells from repairing their DNA, leading to cell death. Ipilimumab, on the other hand, is an immunotherapy drug that helps the immune system recognize and attack cancer cells more effectively. This combination could potentially offer a powerful one-two punch against pancreatic cancer, providing a new hope for patients battling this challenging disease.

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

This trial will compare the combination of niraparib and ipilimumab with the standard chemotherapy FOLFIRI for pancreatic cancer. Studies have shown promising results for using niraparib and ipilimumab together to treat cancer. Specifically, research indicates that this combination achieved the main goal of having patients live for 6 months without their cancer worsening. This suggests that niraparib and ipilimumab can effectively slow tumor growth. In a study with 40 patients, this treatment demonstrated strong anti-tumor activity, helping to stop tumors from growing. These findings support the potential effectiveness of this treatment combination for pancreatic cancer.¹ ² ³ ⁵ ⁶

Are You a Good Fit for This Trial?

This trial is for patients with metastatic pancreatic adenocarcinoma who haven't had their disease progress on platinum-based chemotherapy. Details about specific inclusion and exclusion criteria are not provided, but typically participants must pass screening procedures to ensure they're suitable for the study.

Inclusion Criteria

I don't need to have measurable disease to join the study.

I am willing to have a biopsy if it's safe for me.

I understand the study and agree to participate by signing the consent form.

See 6 more

Exclusion Criteria

I've had severe blood issues from past chemo that lasted more than 4 weeks.

I have not received a live vaccine in the last 4 weeks.

I have a history of lung scarring or inflammation not caused by infection.

See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either niraparib plus ipilimumab every 3 weeks (Arm A) or standard chemotherapy every 2 weeks (Arm B)

Up to 42 months

Regular clinic visits for checkups and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days after End of Treatment Visit

What Are the Treatments Tested in This Trial?

Interventions

Ipilimumab
Niraparib

Trial Overview The trial tests niraparib plus ipilimumab (Arm A) against standard chemotherapy (Arm B) in preventing tumor growth in pancreatic cancer. Patients will be randomly assigned to one of these treatments and receive them at regular intervals while undergoing checkups and tests.

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Group I: Niraparib + Ipilimumab (Arm A)Experimental Treatment2 Interventions

niraparib + ipilimumab

Group II: FOLFIRI (Arm B)Experimental Treatment1 Intervention

standard chemotherapy FOLFIRI

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Published Research Related to This Trial

Combining nivolumab and ipilimumab shows improved effectiveness in treating metastatic melanoma compared to using either drug alone, based on a retrospective analysis of approximately 7700 patients.

The combination therapy presents a safety profile that includes immune-related adverse events from both drugs, indicating that while the combination is effective, it also carries a heightened risk of toxicity that needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data.Soldatos, TG., Dimitrakopoulou-Strauss, A., Larribere, L., et al.[2022]

A study analyzing 70,330 adverse events reported to the FDA found that immune checkpoint inhibitors (ICIs) significantly increase the risk of gastrointestinal (GI) toxicities, particularly colitis, hepatobiliary disorders, and pancreatitis, with colitis showing the highest reporting odds ratio of 17.2.

The risk of these GI adverse events was notably higher with anti-CTLA-4 treatments compared to anti-PD-1 and anti-PD-L1 therapies, and factors such as female gender and polytherapy were identified as strong risk factors for these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Immune-Related Adverse Events of Immune Checkpoint Inhibitors in the Gastrointestinal System: A Study Based on the US Food and Drug Administration Adverse Event Reporting System.Bai, X., Jiang, S., Zhou, Y., et al.[2021]

Immune checkpoint inhibitors like nivolumab, used for treating advanced cancers such as renal cell carcinoma, can lead to rare but serious immune-related adverse events (irAEs), including acute pancreatitis and colitis.

In this case, the patient experienced these irAEs simultaneously but showed significant improvement after receiving corticosteroid therapy, highlighting the importance of monitoring and managing side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Simultaneous Onset of Pancreatitis and Colitis as Immune-related Adverse Events in a Patient Receiving Nivolumab Treatment for Renal Cell Carcinoma.Yazaki, T., Moriyama, I., Tobita, H., et al.[2022]

Citations

1.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC9339497/

A Randomized Phase Ib/II Study of Niraparib plus Nivolumab ...Eighty-four patients were evaluable for the PFS endpoint (44 niraparib/nivolumab; 40 niraparib/ipilimumab). Median follow-up was 23 months (IQR: 15-31.5mo).

2.clinicaltrials.govclinicaltrials.gov/study/NCT06747845

NCT06747845 | Maintenance Niraparib Plus Ipilimumab in ...The main goal of this study is to look at the effectiveness and anti-tumor activity (preventing growth of the tumor) of the drugs niraparib and ipilimumab, ...

3.thelancet.comthelancet.com/journals/lanonc/article/PIIS1470-2045(22)00369-2/abstract

a randomised, phase 1b/2 trialThe primary endpoint of 6-month progression-free survival was met in the niraparib plus ipilimumab maintenance group, whereas niraparib plus ...

4.sciencedirect.comsciencedirect.com/science/article/abs/pii/S1470204522003692

Niraparib plus nivolumab or niraparib plus ipilimumab in ...The primary endpoint of 6-month progression-free survival was met in the niraparib plus ipilimumab maintenance group, whereas niraparib plus nivolumab yielded ...

5.ascopubs.orgascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.4021

A randomized phase Ib/II study of niraparib (nira) plus ...88% of AEs were grade 1-2. Efficacy results were: nira/nivo: PFS6 20.6% (95% CI 8.3-32.9, p = 0.0002), mPFS 1.9 mo and nira/ ...

6.onclive.comonclive.com/view/maintenance-with-niraparib-and-ipilimumab-demonstrates-pfs-benefit-in-pancreatic-cancer

Maintenance With Niraparib and Ipilimumab Demonstrates ...Niraparib plus ipilimumab maintenance therapy elicited encouraging progression-free survival results in patients with advanced pancreatic cancer.

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