Trial Outcomes & Findings for AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer (NCT NCT04430036)
NCT ID: NCT04430036
Last Updated: 2024-04-04
Results Overview
pT0 or pCR (defined as no residual tumor in bladder and lymph nodes on resected specimen). Surgery should be performed within 6 weeks after completing up to 4 cycles (last dose) of neoadjuvant therapy, but can be done up to 10 weeks after treatment ends to be evaluable. Otherwise this patient must be replaced for response evaluation.
TERMINATED
PHASE2
4 participants
Completion of four 21 day cycles (approximately 10 weeks)
2024-04-04
Participant Flow
The safety run-in phase will enroll initial subjects who will begin treatment with cisplatin and gemcitabine plus AGEN2034 and AGEN 19884. Dose limiting toxicities will be assessed before beginning Phase ll, Stage 1. Evaluation will occur after 2 cycles of therapy prior to administration of third and fourth cycle therapy and progression to planned surgery. If criteria are met to continue to Stage 2, additional subjects will be enrolled to reach the anticipated total of 36 subjects.
Participant milestones
| Measure |
Cisplatin, Gemcitabine Plus Human Monoclonal Antibodies
Patients will be treated and endpoints evaluated:
AGEN1884: A fully human monoclonal Anti-PD-1 Antibody AGEN2034: A fully human monoclonal Anti-PD-1 Antibody Cisplatin: Alkylating antineoplastic agent Gemcitabine: Antimetabolite antineoplastic agent
|
|---|---|
|
Safety Run in Phase
STARTED
|
4
|
|
Safety Run in Phase
COMPLETED
|
2
|
|
Safety Run in Phase
NOT COMPLETED
|
2
|
|
Phase II, Stage 1
STARTED
|
0
|
|
Phase II, Stage 1
COMPLETED
|
0
|
|
Phase II, Stage 1
NOT COMPLETED
|
0
|
|
Phase ll, Stage 2
STARTED
|
0
|
|
Phase ll, Stage 2
COMPLETED
|
0
|
|
Phase ll, Stage 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Cisplatin, Gemcitabine Plus Human Monoclonal Antibodies
Patients will be treated and endpoints evaluated:
AGEN1884: A fully human monoclonal Anti-PD-1 Antibody AGEN2034: A fully human monoclonal Anti-PD-1 Antibody Cisplatin: Alkylating antineoplastic agent Gemcitabine: Antimetabolite antineoplastic agent
|
|---|---|
|
Safety Run in Phase
Progression of disease
|
2
|
Baseline Characteristics
AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Cisplatin, Gemcitabine Plus Human Monoclonal Antibodies
n=4 Participants
Participants enrolled with muscle-invasive bladder cancer.
|
|---|---|
|
Age, Continuous
|
59.75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 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
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Completion of four 21 day cycles (approximately 10 weeks)pT0 or pCR (defined as no residual tumor in bladder and lymph nodes on resected specimen). Surgery should be performed within 6 weeks after completing up to 4 cycles (last dose) of neoadjuvant therapy, but can be done up to 10 weeks after treatment ends to be evaluable. Otherwise this patient must be replaced for response evaluation.
Outcome measures
| Measure |
Cisplatin, Gemcitabine Plus Human Monoclonal Antibodies
n=4 Participants
Treatment with the following drugs:
AGEN1884: A fully human monoclonal Anti-PD-1 Antibody
AGEN2034: A fully human monoclonal Anti-PD-1 Antibody
Cisplatin: Alkylating antineoplastic agent
Gemcitabine: Antimetabolite antineoplastic agent
|
|---|---|
|
Pathologic Tumor Downstaging of >T2 to pT0
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to 90 daysEvaluation of safety and tolerability of using Agen1884 plus AGEN2034 plus cisplating and gemcitabine chemotherapy in the neoadjuvant treatment of muscle-invasive bladder cancer prior to radial cystectomy. Number of adverse events assessed between 3-5 using the National Cancer Institution Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Outcome measures
| Measure |
Cisplatin, Gemcitabine Plus Human Monoclonal Antibodies
n=4 Participants
Treatment with the following drugs:
AGEN1884: A fully human monoclonal Anti-PD-1 Antibody
AGEN2034: A fully human monoclonal Anti-PD-1 Antibody
Cisplatin: Alkylating antineoplastic agent
Gemcitabine: Antimetabolite antineoplastic agent
|
|---|---|
|
Evaluation of Safety and Tolerability of AGEN1884 Plus AGEN2034 Plus Cisplatin and Gemcitabine
|
5 adverse events
|
SECONDARY outcome
Timeframe: Baseline to Completion of four 21 day cycles (approximately 10 weeks)Number of subjects who achieved downstaging of the tumor at completion of the possible 4 chemotherapy cycles.
Outcome measures
| Measure |
Cisplatin, Gemcitabine Plus Human Monoclonal Antibodies
n=4 Participants
Treatment with the following drugs:
AGEN1884: A fully human monoclonal Anti-PD-1 Antibody
AGEN2034: A fully human monoclonal Anti-PD-1 Antibody
Cisplatin: Alkylating antineoplastic agent
Gemcitabine: Antimetabolite antineoplastic agent
|
|---|---|
|
Pathologic Downstaging to <T2 Rate
|
3 Participants
|
SECONDARY outcome
Timeframe: 90 daysNumber of subjects that progressed from therapy to surgery
Outcome measures
| Measure |
Cisplatin, Gemcitabine Plus Human Monoclonal Antibodies
n=4 Participants
Treatment with the following drugs:
AGEN1884: A fully human monoclonal Anti-PD-1 Antibody
AGEN2034: A fully human monoclonal Anti-PD-1 Antibody
Cisplatin: Alkylating antineoplastic agent
Gemcitabine: Antimetabolite antineoplastic agent
|
|---|---|
|
Completion of Surgery
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to early termination of the study, data were not collected for this outcome measure
Number of subjects that survived to 1 year from study start without disease progression
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: Due to early termination, not data were collected for this outcome
To correlate clinical outcomes with immune and biologic endpoints and identify patient and tumor characteristics that can predict treatment responses
Outcome measures
Outcome data not reported
Adverse Events
Cisplatin, Gemcitabine Plus Human Monoclonal Antibodies
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cisplatin, Gemcitabine Plus Human Monoclonal Antibodies
n=4 participants at risk
Treatment with the following drugs:
AGEN1884: A fully human monoclonal Anti-PD-1 Antibody
AGEN2034: A fully human monoclonal Anti-PD-1 Antibody
Cisplatin: Alkylating antineoplastic agent
Gemcitabine: Antimetabolite antineoplastic agent
|
|---|---|
|
General disorders
Anorexia
|
25.0%
1/4 • Number of events 1 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Hepatobiliary disorders
Aspartate aminotransferase increase
|
25.0%
1/4 • Number of events 3 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
2/4 • Number of events 2 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
1/4 • Number of events 1 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Renal and urinary disorders
Dysuria
|
50.0%
2/4 • Number of events 2 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 7 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • Number of events 2 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
General disorders
Headache
|
25.0%
1/4 • Number of events 2 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Renal and urinary disorders
Hyperkalemia
|
25.0%
1/4 • Number of events 1 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
General disorders
Hypertension
|
25.0%
1/4 • Number of events 3 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Renal and urinary disorders
Hypokalemia
|
25.0%
1/4 • Number of events 3 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
General disorders
Hypotension
|
25.0%
1/4 • Number of events 2 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 4 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
50.0%
2/4 • Number of events 5 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • Number of events 1 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
General disorders
Other
|
50.0%
2/4 • Number of events 3 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Number of events 1 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Vascular disorders
Thromboembolic event
|
25.0%
1/4 • Number of events 1 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Infections and infestations
Tooth infection
|
25.0%
1/4 • Number of events 1 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Renal and urinary disorders
Urinary frequency
|
50.0%
2/4 • Number of events 2 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Infections and infestations
Urinary tract infection
|
50.0%
2/4 • Number of events 2 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
General disorders
Weight loss
|
25.0%
1/4 • Number of events 1 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
|
Blood and lymphatic system disorders
White blood cells decreased
|
25.0%
1/4 • Number of events 3 • Baseline to approximately 5 days after last treatment (approximately 10 weeks)
|
Additional Information
Robert Svatek, MD
University of Texas Health Science Center at San Antonio
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place