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NCT04074967 · ClinicalTrials.gov registry record · Phase 1
Study of ARRY-614 Plus Either Nivolumab or Nivolumab+Ipilimumab
A Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Dan Zandberg.
- Active
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT04074967: Active Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Dan Zandberg.
NCT04074967 is a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma that is active but no longer recruiting, run by Dan Zandberg. The registered enrollment target is 70 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04074967, a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, is active but no longer recruiting, sponsored by Dan Zandberg.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, the Phase Ib portion aims to establish safety and tolerability of ARRY-614 with either nivolumab or ipilimumab and to determine a recommended phase II dose of ARRY-614 in combination with either nivolumab or nivolumab+ipilimumab immunotherapy in patients with selected advanced solid tumors. The Phase II portion will estimate the efficacy of ARRY-614 in combination with either nivolumab or ARRY-614 + nivolumab+ipilimumab immunotherapy in patients with with NSCLC, HNSCC, melanoma and RCC and melanoma.
Primary Outcome
Safety and recommended Phase ll dose of ARRY-614 in combination with either nivolumab or or nivolumab+ipilimumab per NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5.0: Any AE (unless attributable to an extraneous cause, ex. disease progression) that satisfies ≥1 of the following: Grade 3 or 4 nausea or vomiting; Grade 3 or 4 nausea or vomiting despite anti emetic prophylaxis; Grade 3 or 4 diarrhea; Grade 3 or 4 diarrhea despite the administration of anti-diarrheals. Other Grade 3
Conditions Studied
Interventions
- DRUG Phase Ib ARRY-614 + nivolumab
- DRUG Phase Ib ARRY-614 + nivolumab+ipilimumab
- DRUG Phase II ARRY-614 + nivolumab
- DRUG Phase II ARRY-614 + nivolumab+ipilimumab (melanoma)
- DRUG Phase II ARRY-614 + nivolumab+ipilimumab (RCC)
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-06-11 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04074967 still lists
NCT04074967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower).
The record links to 5 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Phase Ib ARRY-614 + nivolumab is the first listed.
NCT04074967 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04074967 about?
NCT04074967 is a clinical study titled "Study of ARRY-614 Plus Either Nivolumab or Nivolumab+Ipilimumab". In this study, the Phase Ib portion aims to establish safety and tolerability of ARRY-614 with either nivolumab or ipilimumab and to determine a recommended phase II dose of ARRY-614 in combination with either nivolumab or nivolumab+ipilimumab immunotherapy in patients with selected advanced solid t...
What is the current status of trial NCT04074967?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2020-06-11. Estimated completion is 2025-12-31.
What conditions does trial NCT04074967 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Melanoma, Solid Tumor, Head and Neck Squamous Cell Carcinoma, Renal Cell Carcinoma.
What interventions are being tested in trial NCT04074967?
The interventions under investigation include: Phase Ib ARRY-614 + nivolumab (DRUG), Phase Ib ARRY-614 + nivolumab+ipilimumab (DRUG), Phase II ARRY-614 + nivolumab (DRUG), Phase II ARRY-614 + nivolumab+ipilimumab (melanoma) (DRUG), Phase II ARRY-614 + nivolumab+ipilimumab (RCC) (DRUG).
Who is sponsoring clinical trial NCT04074967?
This trial is sponsored by Dan Zandberg, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04074967 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04074967's enrollment target sits among peer trials
70 289th of 454 higher than 161 of 454 other Non-Small Cell Lung Cancer trials
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