Trial Outcomes & Findings for Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (NCT NCT04093323)
NCT ID: NCT04093323
Last Updated: 2026-02-25
Results Overview
Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be carried out by an exact binomial test of a proportion within a Simon two-stage design.
TERMINATED
PHASE2
1 participants
At 12 weeks
2026-02-25
Participant Flow
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Participant milestones
| Measure |
Treatment (IFNA2, Rintatolimod, Celecoxib, alphaDC1 Cell Based Treatment)
Patients receive recombinant interferon alpha-2 IV over 30 minutes, rintatolimod IV over 2.5 hours, and celecoxib PO BID on days 1-3. Beginning cycle 2, patients also receive alpha-type-1 polarized dendritic cells ID on day 1. Treatment repeats every 3 weeks up to 4 cycles in the absence of disease progression or unacceptable toxicity. At 12 weeks, patients with progressive disease may switch to ipilimumab with or without a PD-1/PD-L1 inhibitor and patients with a complete response CR, PR, or stable disease SD may switch to a PD-1/PD-L1 inhibitor or best alternative care.
Alpha-type-1 Polarized Dendritic Cells: Given ID
Celecoxib: Given PO
PD-1 Ligand Inhibitor: Given IV
PD1 Inhibitor: Given IV
Recombinant Interferon Alfa-2b: Given IV
Rintatolimod: Given IV
|
|---|---|
|
Overall Study
STARTED
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: At 12 weeksPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be carried out by an exact binomial test of a proportion within a Simon two-stage design.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 monthsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Will be evaluated using immune-related RECIST (iRECIST) criteria in patients that continue on with either PD1 and/or CTLA4 blockade after meeting the 12-week primary objective treated with autologous alpha-type-1 polarized dendritic cells (alphaDC1)/tumor blood vessel-targeting antigenic peptides (TBVA) cell-based treatment plus cytokine modulating (CKM) regimen followed by re-treatment with PD1 blockade (+/- CTLA4 blockade). The analysis will be primarily descriptive and consist of sample proportions and the corresponding 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From time of first confirmed response assessed up to 2 yearsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Will be evaluated on patients treated autologous alphaDC1/TBVA cell-based treatment plus cytokine CKM regimen followed by retreatment with PD1 blockade (+/- CTLA4 blockade). The analysis will be primarily descriptive and consist of sample proportions and the corresponding 95% confidence intervals.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Will be evaluated using iRECIST criteria. Will be compared to the historical control of the best supportive care and to identify the intratumoral and systemic immune correlates of the response to treatment. Will be analyzed by a Cox regression model as a function of various biomarker combinations.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Will be compared to the historical control of the best supportive care and to identify the intratumoral and systemic immune correlates of the response to treatment. Will be analyzed by a Cox regression model as a function of various biomarker combinations.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to week 11Population: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Will be evaluated using the OmniSeq immune report card (IRC). Will be analyzed by a Cox regression model as a function of various biomarker combinations.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to week 11Population: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Will be evaluated using the OmniSeq IRC. Will be analyzed by a Cox regression model as a function of various biomarker combinations.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (IFNA2, Rintatolimod, Celecoxib, alphaDC1 Cell Based Treatment)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place