Trial Outcomes & Findings for Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver (NCT NCT03403634)

Last Updated: 2022-03-02

Results Overview

The TILs will be summarized by time-point (pre-/post-treatment) using the mean, median, standard deviation; and graphically using dot-plots. The TIL of interest is CD8a expression, which is reported as the mean fold change from pre-treatment (i.e. post treatment / pre treatment).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Baseline up to 12 months

Results posted on

2022-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod) Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Alfa-2b: Given IV Rintatolimod: Given IV
Overall Study STARTED	19
Overall Study Treated	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod) Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Alfa-2b: Given IV Rintatolimod: Given IV
Overall Study Disease progression	3
Overall Study Did not meet eligibility criteria	4

Baseline Characteristics

Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod) n=15 Participants Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Alfa-2b: Given IV Rintatolimod: Given IV
Age, Continuous	60.5 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Line of Treatment Third Line	5 Participants n=5 Participants
Line of Treatment Fourth Line	6 Participants n=5 Participants
Line of Treatment Fifth or More Line	4 Participants n=5 Participants
Clinical Stage Stage I	0 Participants n=5 Participants
Clinical Stage Stage II	0 Participants n=5 Participants
Clinical Stage Stage III	0 Participants n=5 Participants
Clinical Stage Stage IV	15 Participants n=5 Participants
Clinical Stage Not Reported	0 Participants n=5 Participants
Location of Disease Cecum	1 Participants n=5 Participants
Location of Disease Colon, NOS	7 Participants n=5 Participants
Location of Disease Rectum, NOS	6 Participants n=5 Participants
Location of Disease Sigmoid Colon	1 Participants n=5 Participants
Prior Radiation	6 Participants n=5 Participants
Prior Surgery	10 Participants n=5 Participants
RAS Type KRAS	5 Participants n=5 Participants
RAS Type NRAS	3 Participants n=5 Participants
RAS Type Wild-type	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 12 months

Population: 3 patients did not have post treatment biopsies, and were considered unevaluable for the primary endpoint.

Outcome measures

Outcome measures
Measure	Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod) n=12 Participants Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Alfa-2b: Given IV Rintatolimod: Given IV
Change in Tumor-infiltrating Lymphocytes (TILs) in the Colorectal Cancer Lesions	7.25 fold change Standard Deviation 13.79

SECONDARY outcome

Timeframe: Up to 12 months

Population: All patients that received study treatment.

Safety profile will be characterized by type, frequency, severity, timing, seriousness and relationship to study treatment. The highest grade treatment related AE is provided (per Common Terminology Criteria for Adverse Events version 4.0).

Outcome measures

Outcome measures
Measure	Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod) n=15 Participants Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Alfa-2b: Given IV Rintatolimod: Given IV
Number of Participants With Indicated Grade Adverse Event No Treatment Related AE Reported	1 Participants
Number of Participants With Indicated Grade Adverse Event Grade I	6 Participants
Number of Participants With Indicated Grade Adverse Event Grade II	7 Participants
Number of Participants With Indicated Grade Adverse Event Grade III	1 Participants
Number of Participants With Indicated Grade Adverse Event Grade IV	0 Participants
Number of Participants With Indicated Grade Adverse Event Grade V	0 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Evaluated in subjects evaluable for the primary end-point.

Will be treated as binary data and summarized using frequencies and relative frequencies; with the ORR estimated using a 90% confidence interval obtained using Jeffrey's prior method.

Outcome measures

Outcome measures
Measure	Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod) n=12 Participants Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Alfa-2b: Given IV Rintatolimod: Given IV
Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the start of treatment until disease progression (defined by RECIST 1.1) or last-follow-up, assessed up to 12 months

Population: Evaluated in subjects evaluable for the primary end-point.

Will be treated as bivariate time-to-event data and will be summarized using standard Kaplan-Meier methods.

Outcome measures

Outcome measures
Measure	Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod) n=12 Participants Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Alfa-2b: Given IV Rintatolimod: Given IV
Progression Free Survival	1.5 Months Interval 1.4 to 1.8

OTHER_PRE_SPECIFIED outcome

Timeframe: From the start of treatment until death due to any cause or last follow-up, assessed up to 12 months

Population: Evaluated in subjects evaluable for the primary end-point.

Will be treated as bivariate time-to-event data and will be summarized using standard Kaplan-Meier methods.

Outcome measures

Outcome measures
Measure	Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod) n=12 Participants Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Alfa-2b: Given IV Rintatolimod: Given IV
Overall Survival	10.5 Months Interval 2.2 to 15.2

Adverse Events

Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)

Serious events: 3 serious events

Other events: 14 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod) n=15 participants at risk Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Alfa-2b: Given IV Rintatolimod: Given IV
Hepatobiliary disorders Hyperbilirubinemia	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm (NOS)	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
General disorders Death	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.

Other adverse events

Other adverse events
Measure	Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod) n=15 participants at risk Patients receive celecoxib orally PO BID, recombinant interferon alfa-2b IV QD over 20 minutes, and rintatolimod IV QD on days 1, 2, 3, 8, 9, 10, 15, 16 and 17 in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO Laboratory Biomarker Analysis: Correlative studies Recombinant Interferon Alfa-2b: Given IV Rintatolimod: Given IV
Gastrointestinal disorders Gastrointestinal disorders **Any AE - Maximum Grade Seen Diarrhoea	20.0% 3/15 • Number of events 3 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Gastrointestinal disorders Dyspepsia	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Gastrointestinal disorders Nausea	26.7% 4/15 • Number of events 4 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Gastrointestinal disorders Vomiting	13.3% 2/15 • Number of events 2 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
General disorders Asthenia	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
General disorders Chills	73.3% 11/15 • Number of events 11 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
General disorders Fatigue	73.3% 11/15 • Number of events 11 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
General disorders Influenza like illness	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Gastrointestinal disorders Pyrexia	33.3% 5/15 • Number of events 5 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Infections and infestations Mucosal infection	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Injury, poisoning and procedural complications Infusion related reaction	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Investigations Aspartate aminotransferase increased	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Investigations Blood alkaline phosphatase increased	13.3% 2/15 • Number of events 2 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Investigations Platelet count decreased	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Investigations Weight decreased	13.3% 2/15 • Number of events 2 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Metabolism and nutrition disorders Decreased appetite	33.3% 5/15 • Number of events 5 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Musculoskeletal and connective tissue disorders Myalgia	13.3% 2/15 • Number of events 2 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Nervous system disorders Dizziness	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Nervous system disorders Headache	20.0% 3/15 • Number of events 3 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Psychiatric disorders Insomnia	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Respiratory, thoracic and mediastinal disorders Sinus congestion	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Vascular disorders Hot flush	40.0% 6/15 • Number of events 6 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.
Vascular disorders Hypotension	6.7% 1/15 • Number of events 1 • Adverse event data was collected up to 30 days after end of treatment, up to 1 year.

Additional Information

Kris Attwood

Roswell Park Comprehensive Cancer Center

Phone: 716-845-1300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place