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Checkpoint Inhibitor

NP-101 + Nivolumab + Ipilimumab for Cancer

Phase 1
Waitlist Available
Led By Amr Mohamed, MD
Research Sponsored by Amr Mohamed MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from the start of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a black seed oil formula combined with two cancer drugs in patients with neuroendocrine carcinoma who did not respond to standard treatments. The formula may enhance the immune system's ability to fight cancer and inhibit tumor growth. Thymoquinone (TQ), the major active ingredient of black seed oil, has been extensively studied for its anti-cancer properties, including promoting apoptosis, arresting the cell cycle, and generating reactive oxygen species.

Who is the study for?
Adults with advanced or metastatic high-grade neuroendocrine carcinomas outside the lungs who have tried at least one treatment without success. They must be in good health otherwise, with normal organ and marrow function, and no unresolved severe side effects from previous treatments. Participants need measurable disease by RECIST criteria, agree to use effective contraception methods if of childbearing potential, and sign a consent form.
What is being tested?
The trial is testing a combination of NP-101 (TQ Formula), derived from black seed with antioxidant properties, along with two immunotherapy drugs: Nivolumab and Ipilimumab. This second-line therapy aims to assess its effectiveness against tumors that didn't respond to initial treatments.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs due to Nivolumab and Ipilimumab such as inflammation or dysfunction; fatigue; skin issues; hormonal changes; digestive disturbances; increased risk of infections; allergic reactions similar to those caused by compounds related to the study medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from the start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from the start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Antitumor activity of NP-101 (TQ Formula) plus nivolumab and ipilimumab in subjects with advanced and/or metastatic EP-NECAs who progressed on first line therapy
Secondary study objectives
Safety profile/toxicity of combining NP-101 (TQ Formula) with nivolumab and ipilimumab.
Time to progression (TTP)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NP-101 (TQ Formula) + Nivolumab + IpilimumabExperimental Treatment3 Interventions

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Neuroendocrine Carcinoma include NP-101 TQ Formula, Nivolumab, and Ipilimumab. NP-101 TQ Formula has anti-oxidant and anti-angiogenic effects, reducing oxidative stress and inhibiting new blood vessel formation essential for tumor growth. Nivolumab, a PD-1 inhibitor, enhances the immune system's ability to attack cancer cells by blocking the programmed cell death protein 1 pathway. Ipilimumab, a CTLA-4 inhibitor, prevents the downregulation of T cells, boosting the immune response against cancer cells. These treatments are significant for Neuroendocrine Carcinoma patients as they provide a comprehensive approach to inhibiting tumor growth and enhancing immune system activity.

Find a Location

Who is running the clinical trial?

Amr Mohamed MDLead Sponsor
Novatek PharmaceuticalsIndustry Sponsor
2 Previous Clinical Trials
363 Total Patients Enrolled
Amr Mohamed, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05262556 — Phase 1
Neuroendocrine Carcinoma Research Study Groups: NP-101 (TQ Formula) + Nivolumab + Ipilimumab
Neuroendocrine Carcinoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05262556 — Phase 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05262556 — Phase 1
~5 spots leftby Oct 2025