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NCT05061017 · ClinicalTrials.gov registry record · Phase 2
Pixatimod (PG545) Plus Nivolumab in PD-1 Relapsed/Refractory Metastatic Melanoma and NSCLC and With Nivolumab and Low-dose Cyclophosphamide in MSS Metastatic Colorectal Carcinoma (mCRC)
A Phase 2 study, sponsored by Diwakar Davar.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT05061017: Completed Phase 2 study, sponsored by Diwakar Davar.
NCT05061017 is a Phase 2 study that has completed, run by Diwakar Davar. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05061017, a Phase 2 study, has completed, sponsored by Diwakar Davar.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary goal of this trial is to assess clinical response to nivolumab and pixatimod, and, nivolumab, pixatimod and cyclophosphamide in three separate patient cohorts. Cohort 1: MSS mCRC in combination with low-dose cyclophosphamide, Cohort 2: PD-1 relapsed/refractory melanoma, and Cohort 3: PD-1 relapsed/refractory NSCLC.
Primary Outcome
Objective Response (rate) will be expressed as the percentage of patients with Complete Response (CR) + Partial Response (PR). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD;Progressive disease (PD) is defined as at least a 20% increas
Interventions
- DRUG Nivolumab
- DRUG Pixatimod
- DRUG Cyclophosphamide (low dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-12-09 |
| Est. Completion | 2024-03-18 |
| Phase | Phase 2 |
What the finished NCT05061017 record still lists
NCT05061017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT05061017 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05061017 about?
NCT05061017 is a clinical study titled "Pixatimod (PG545) Plus Nivolumab in PD-1 Relapsed/Refractory Metastatic Melanoma and NSCLC and With Nivolumab and Low-dose Cyclophosphamide in MSS Metastatic Colorectal Carcinoma (mCRC)". The primary goal of this trial is to assess clinical response to nivolumab and pixatimod, and, nivolumab, pixatimod and cyclophosphamide in three separate patient cohorts. Cohort 1: MSS mCRC in combination with low-dose cyclophosphamide, Cohort 2: PD-1 relapsed/refractory melanoma, and Cohort 3: PD-...
What is the current status of trial NCT05061017?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2021-12-09. Estimated completion is 2024-03-18.
What interventions are being tested in trial NCT05061017?
The interventions under investigation include: Nivolumab (DRUG), Pixatimod (DRUG), Cyclophosphamide (low dose) (DRUG).
Who is sponsoring clinical trial NCT05061017?
This trial is sponsored by Diwakar Davar, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05061017's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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