Trial Outcomes & Findings for Abemaciclib and Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer (NCT NCT03938337)
NCT ID: NCT03938337
Last Updated: 2021-07-09
Results Overview
Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans
TERMINATED
PHASE2
1 participants
Baseline
2021-07-09
Participant Flow
Participant milestones
| Measure |
Cohort 1 Not Previously Treated
Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.
Cohort 1 Not Previously Treated: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks
|
Cohort 2 Treated Previously
Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.
Cohort 2 Treated Previously: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Abemaciclib and Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1 Not Previously Treated
n=1 Participants
Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.
Cohort 1 Not Previously Treated: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks
|
Cohort 2 Treated Previously
Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.
Cohort 2 Treated Previously: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to 5 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to 8 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 1 monthPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
Measure adverse events grade 3 or greater to evaluate safety and tolerability
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
Measure adverse events grade 3 or greater to evaluate safety and tolerability
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
Measure adverse events grade 3 or greater to evaluate safety and tolerability
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
Using scan results to assess whether tumor has progressed and the time;
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 12 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
Using scan results to assess whether tumor has progressed and the time;
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
time that the patient is experiencing survival
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 12 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
time that the patient is experiencing survival
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
using scan results to assess the time it takes for the tumor to respond to treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 12 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
using scan results to assess the time it takes for the tumor to respond to treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
using scan results to measure the total amount of time that the tumor is responding to treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 12 monthsPopulation: No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination
using scan results to measure the total amount of time that the tumor is responding to treatment
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 Not Previously Treated
Cohort 2 Treated Previously
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 Not Previously Treated
n=1 participants at risk
Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.
Cohort 1 Not Previously Treated: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks
|
Cohort 2 Treated Previously
Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.
Cohort 2 Treated Previously: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Afebrile neutropenia
|
100.0%
1/1 • Number of events 2 • Baseline through 8 months
Since study terminated prematurely due to toxicity from other trials with this combination, there were no SAEs and no mortality observed
|
—
0/0 • Baseline through 8 months
Since study terminated prematurely due to toxicity from other trials with this combination, there were no SAEs and no mortality observed
|
|
Renal and urinary disorders
Creatinine Increased
|
100.0%
1/1 • Number of events 1 • Baseline through 8 months
Since study terminated prematurely due to toxicity from other trials with this combination, there were no SAEs and no mortality observed
|
—
0/0 • Baseline through 8 months
Since study terminated prematurely due to toxicity from other trials with this combination, there were no SAEs and no mortality observed
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
1/1 • Number of events 1 • Baseline through 8 months
Since study terminated prematurely due to toxicity from other trials with this combination, there were no SAEs and no mortality observed
|
—
0/0 • Baseline through 8 months
Since study terminated prematurely due to toxicity from other trials with this combination, there were no SAEs and no mortality observed
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Baseline through 8 months
Since study terminated prematurely due to toxicity from other trials with this combination, there were no SAEs and no mortality observed
|
—
0/0 • Baseline through 8 months
Since study terminated prematurely due to toxicity from other trials with this combination, there were no SAEs and no mortality observed
|
Additional Information
Eddy S. Yang
O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place