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NCT02535247 · ClinicalTrials.gov registry record · Phase 1
Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma
A Phase 1 study, sponsored by Fox Chase Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02535247: Clinical Trial Phase 1 study, sponsored by Fox Chase Cancer Center.
NCT02535247 is a Phase 1 study that was terminated before completion, run by Fox Chase Cancer Center. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02535247, a Phase 1 study, was terminated before completion, sponsored by Fox Chase Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This is a multicenter, single-arm, open label, study consisting of two cohorts. Cohort 2 explores the combination of copanlisib and pembrolizumab in patients with relapsed or refractory NKTCL, who have received at least 1 prior systemic therapy. Cohort 2 will include a phase 1 portion (cohort 2a) to determine the recommended phase 2 dose (RP2D) utilizing a standard 3+3 design, followed by a phase II portion where patients will be treated at the RP2D (cohort 2b). The primary endpoint for cohort 1 was progression-free survival; the primary endpoint for cohort 2a will be to determine RP2D for the combination therapy; and overall response rate at the end of 4 treatment cycles for cohort 2b. Patients will be assessed for response with PET CT or CT every 12 weeks using the revised Cheson criteria. Correlative endpoints will be exploratory and assess PD-1 expression on peripheral blood lymphocytes; peripheral blood T-cell and NK-cell functional assays; PD-1 and PD-L1 expression on tumor tissue; tumor infiltrating lymphocytes and gene expression panels using the nanostring technology as prognostic and predictive biomarkers, as well as monitoring of minimal residual disease via high-throughput sequencing of cell free tumor DNA, and exosome analysis.
Primary Outcome
Based on RECIST v1.1
Interventions
- DRUG Copanlisib
- DRUG MK-3475
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2016-01-05 |
| Est. Completion | 2020-02-25 |
| Phase | Phase 1 |
Why NCT02535247 stopped before completion
NCT02535247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Copanlisib is the first listed.
NCT02535247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02535247 about?
NCT02535247 is a clinical study titled "Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma". This is a multicenter, single-arm, open label, study consisting of two cohorts. Cohort 2 explores the combination of copanlisib and pembrolizumab in patients with relapsed or refractory NKTCL, who have received at least 1 prior systemic therapy. Cohort 2 will include a phase 1 portion (cohort 2a) to...
What is the current status of trial NCT02535247?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2016-01-05. Estimated completion is 2020-02-25.
What interventions are being tested in trial NCT02535247?
The interventions under investigation include: Copanlisib (DRUG), MK-3475 (DRUG).
Who is sponsoring clinical trial NCT02535247?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02535247's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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