Trial Outcomes & Findings for CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma (NCT NCT04387071)
NCT ID: NCT04387071
Last Updated: 2026-04-17
Results Overview
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions. All proportions will be estimated using an exact 95% binomial confidence interval.
TERMINATED
PHASE1/PHASE2
2 participants
Through end of treatment, up to 2 months
2026-04-17
Participant Flow
The study began recruiting in April 2021 and recruitment ended in December 2022. All participants were seen and treated at USC Norris Comprehensive Cancer Center.
Participant milestones
| Measure |
Dose Level 1 (CMP-001, INCAGN01949)
Patients receive CMP-001 at 5 mg SC on day 1 of weeks 1 and 2 and 10 mg IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity. Patients also receive INCAGN01949 at 500 mcg/m\^2 IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity.
Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949: Given IT
VLP-encapsulated TLR9 Agonist CMP-001: Given SC and IT
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (CMP-001, INCAGN01949)
n=2 Participants
Patients receive CMP-001 SC on day 1 of weeks 1 and 2 and IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity. Patients also receive INCAGN01949 IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity.
Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949: Given IT
VLP-encapsulated TLR9 Agonist CMP-001: Given SC and IT
|
|---|---|
|
Sex: Female, Male
Female
|
0 Participants
n=130 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=130 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=130 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=130 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=130 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=130 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=130 Participants
|
|
ECOG Score at Baseline
0
|
2 Participants
n=130 Participants
|
|
ECOG Score at Baseline
1
|
0 Participants
n=130 Participants
|
|
ECOG Score at Baseline
2
|
0 Participants
n=130 Participants
|
|
ECOG Score at Baseline
3
|
0 Participants
n=130 Participants
|
|
ECOG Score at Baseline
4
|
0 Participants
n=130 Participants
|
|
ECOG Score at Baseline
5
|
0 Participants
n=130 Participants
|
|
Site of Primary Disease at Diagnosis
Exocrine Pancreas
|
1 Participants
n=130 Participants
|
|
Site of Primary Disease at Diagnosis
Ampulla of Vater
|
1 Participants
n=130 Participants
|
|
Tumor Clinical Stage at Study Entry
0
|
0 Participants
n=130 Participants
|
|
Tumor Clinical Stage at Study Entry
I
|
0 Participants
n=130 Participants
|
|
Tumor Clinical Stage at Study Entry
II
|
0 Participants
n=130 Participants
|
|
Tumor Clinical Stage at Study Entry
III
|
0 Participants
n=130 Participants
|
|
Tumor Clinical Stage at Study Entry
IV
|
2 Participants
n=130 Participants
|
|
Tumor Clinical Stage at Study Entry
IE
|
0 Participants
n=130 Participants
|
|
Tumor Clinical Stage at Study Entry
IIE
|
0 Participants
n=130 Participants
|
|
Number of Patients Receiving Prior Treatments
Chemotherapy
|
2 Participants
n=130 Participants
|
|
Number of Patients Receiving Prior Treatments
Radiation therapy
|
1 Participants
n=130 Participants
|
|
Number of Patients Receiving Prior Treatments
Immunotherapy
|
1 Participants
n=130 Participants
|
|
Number of Patients Receiving Prior Treatments
Surgery
|
2 Participants
n=130 Participants
|
PRIMARY outcome
Timeframe: Through end of treatment, up to 2 monthsPopulation: All enrolled subjects were included in the analysis.
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions. All proportions will be estimated using an exact 95% binomial confidence interval.
Outcome measures
| Measure |
Treatment (CMP-001, INCAGN01949)
n=2 Participants
Patients receive CMP-001 SC on day 1 of weeks 1 and 2 and IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity. Patients also receive INCAGN01949 IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity.
Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949: Given IT
VLP-encapsulated TLR9 Agonist CMP-001: Given SC and IT
|
|---|---|
|
Disease Control Rate
Complete Response
|
0 Participants
|
|
Disease Control Rate
Partial Response
|
0 Participants
|
|
Disease Control Rate
Stable Disease
|
0 Participants
|
|
Disease Control Rate
No response
|
0 Participants
|
|
Disease Control Rate
Progressive disease
|
2 Participants
|
PRIMARY outcome
Timeframe: Through end of treatment, up to 2 months.Population: All enrolled subjects are included in the analysis.
Will be evaluated using the RECIST 1.1 and iRECIST. Changes (i.e. improvements) in tumor measurements from baseline values will be assigned a status of complete response (CR) or partial response (PR) or stable disease (SD). Objective response measurements will comprise the sum of CR plus PR.
Outcome measures
| Measure |
Treatment (CMP-001, INCAGN01949)
n=2 Participants
Patients receive CMP-001 SC on day 1 of weeks 1 and 2 and IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity. Patients also receive INCAGN01949 IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity.
Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949: Given IT
VLP-encapsulated TLR9 Agonist CMP-001: Given SC and IT
|
|---|---|
|
Objective Response Rate (CR + PR)
Complete + Partial Response
|
0 Participants
|
|
Objective Response Rate (CR + PR)
No Response
|
2 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 9 monthsAll adverse events occurring on or after week 1/day 1 will be summarized by body systems and per grade according to National Cancer Institute (NCI)-Common Terminology Criteria (CTC) version 5.
Outcome measures
| Measure |
Treatment (CMP-001, INCAGN01949)
n=2 Participants
Patients receive CMP-001 SC on day 1 of weeks 1 and 2 and IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity. Patients also receive INCAGN01949 IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity.
Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949: Given IT
VLP-encapsulated TLR9 Agonist CMP-001: Given SC and IT
|
|---|---|
|
Incidence of Adverse Events
|
2 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 9 monthsPopulation: All enrolled subjects were included in the analysis.
PFS is defined as the interval from the date of registration (i.e. assignment of patient number) to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first. All proportions will be estimated using an exact 95% binomial confidence interval, and a Kaplan-Meier analysis will be performed.
Outcome measures
| Measure |
Treatment (CMP-001, INCAGN01949)
n=2 Participants
Patients receive CMP-001 SC on day 1 of weeks 1 and 2 and IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity. Patients also receive INCAGN01949 IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity.
Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949: Given IT
VLP-encapsulated TLR9 Agonist CMP-001: Given SC and IT
|
|---|---|
|
Progression Free Survival (PFS)
|
2.9 Months
Interval 2.9 to
The upper limit of confidence interval with this study data is not able to be calculated with only 2 patients enrolled.
|
SECONDARY outcome
Timeframe: Through study completion, up to 9 monthsPopulation: All enrolled subjects were included in the analysis.
Will be measured from the date of registration (i.e. assignment of patient number) to the date of death due to any cause, or the date of last contact (censored observations). All proportions will be estimated using an exact 95% binomial confidence interval, and a Kaplan-Meier analysis will be performed.
Outcome measures
| Measure |
Treatment (CMP-001, INCAGN01949)
n=2 Participants
Patients receive CMP-001 SC on day 1 of weeks 1 and 2 and IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity. Patients also receive INCAGN01949 IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity.
Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949: Given IT
VLP-encapsulated TLR9 Agonist CMP-001: Given SC and IT
|
|---|---|
|
Overall Survival
|
1.6 Months
Lower and upper limit of confidence interval with this study is not able to be calculated with only 2 patients enrolled.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 9 monthsPopulation: No analysis done with only 2 subjects enrolled.
Will be analyzed by flow cytometry on peripheral blood, within the lymphocyte subsets (Teffs and Tregs).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 9 monthsPopulation: No analysis done with only 2 subjects enrolled.
Will be enumerated using flow cytometry.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 9 monthsPopulation: No analysis done with only 2 subjects enrolled.
Will analyze CD127, HLA-DR, CD45RO, CCR7, CXCR3 using flow cytometry.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 9 monthsPopulation: No analysis done with only 2 subjects enrolled.
Will be analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR) and sequencing.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, up to 9 monthsPopulation: No analysis done with only 2 subjects enrolled.
Will perform ribonucleic acid sequencing (RNASeq) to determine immune cell populations including T cells and macrophages.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (CMP-001, INCAGN01949)
Serious adverse events
| Measure |
Treatment (CMP-001, INCAGN01949)
n=2 participants at risk
Patients receive CMP-001 SC on day 1 of weeks 1 and 2 and IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity. Patients also receive INCAGN01949 IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity.
Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949: Given IT
VLP-encapsulated TLR9 Agonist CMP-001: Given SC and IT
|
|---|---|
|
Investigations
Lymphocyte Count Decreased
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Through study completion, up to 9 months
|
Other adverse events
| Measure |
Treatment (CMP-001, INCAGN01949)
n=2 participants at risk
Patients receive CMP-001 SC on day 1 of weeks 1 and 2 and IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity. Patients also receive INCAGN01949 IT on day 1 of weeks 3-6 in the absence of disease progression or unacceptable toxicity.
Agonistic Anti-OX40 Monoclonal Antibody INCAGN01949: Given IT
VLP-encapsulated TLR9 Agonist CMP-001: Given SC and IT
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Cardiac disorders
Sinus Tachycardia
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Gastrointestinal disorders
Dry Mouth
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Gastrointestinal disorders
Mild Esophageal Dysmotility
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Gastrointestinal disorders
vomiting
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
General disorders
Chills
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
General disorders
Edema Limbs
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
General disorders
Fatigue
|
100.0%
2/2 • Through study completion, up to 9 months
|
|
General disorders
Fever
|
100.0%
2/2 • Through study completion, up to 9 months
|
|
General disorders
Injection Site Reaction
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Investigations
Alkaline Phosphatase Increased
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
2/2 • Through study completion, up to 9 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
2/2 • Through study completion, up to 9 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
2/2 • Through study completion, up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Renal and urinary disorders
Hematuria
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
50.0%
1/2 • Through study completion, up to 9 months
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
50.0%
1/2 • Through study completion, up to 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place