NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Amr Mohamed MD
Study ID
NCT05262556
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • NP-101 (TQ Formula) — DRUG
    Oral, five 600mg tabs daily every three weeks for four cycles (21-day cycle), then maintenance for an additional 12 weeks for a total of six cycles.
  • Nivolumab (3mg/kg) — DRUG
    Intravenously on Day 1 every three weeks for four cycles (maximum dose 360mg once every 3 weeks), then 240mg maintenance every two weeks for six cycles for a total of six months of treatment.
  • Ipilimumab (1mg/kg) — DRUG
    Intravenously on day 1 of each (21-day) cycle for a total of four cycles only.

Study Details

A pilot study to evaluate the anti-tumor efficacy of this novel combined regimen (NP-101 TQ Formula plus nivolumab and ipilimumab) in the second-line setting for EP-NECA. NP-101 (TQ Formula) (TQ, C10H12O2) is the main bioactive component of the black seed (Nigella sativa, Ranunculaceae family) and has anti-oxidant, anti-angiogenic effects.

Key Dates

Start date
Dec 15, 2022
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NP-101 (TQ Formula) + Nivolumab + Ipilimumab

Primary Outcome Measure

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 [ Time Frame: Up to 6 months from the start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106-

Find similar trials in Cleveland, OH

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
University hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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