Trial Outcomes & Findings for Sintilimab in Cancer of Unknown Primary (NCT NCT05024968)
NCT ID: NCT05024968
Last Updated: 2026-02-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
1 year
Results posted on
2026-02-25
Participant Flow
Recruitment was at MD Anderson Cancer Center
Participants were eligible if they were refractory or intolerant to one line of systemic therapy or had a contraindication for cytotoxic chemotherapy.
Participant milestones
| Measure |
Sintilimab 200 mg IV Every 3 Weeks
Participants with unresectable, locally advanced, recurrent or metastatic Cancer of Unknown Primary (CUP)
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sintilimab in Cancer of Unknown Primary
Baseline characteristics by cohort
| Measure |
Sintilimab 200 mg IV Every 3 Weeks
n=10 Participants
Participants with unresectable, locally advanced, recurrent or metastatic Cancer of Unknown Primary (CUP)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Sintilimab 200 mg IV Every 3 Weeks
n=10 Participants
Participants with unresectable, locally advanced, recurrent or metastatic Cancer of Unknown Primary (CUP)
|
|---|---|
|
Confirmed Objective Response Rate (cORR) by RECISTv1.1
|
40 percentage of participants
Interval 12.2 to 73.2
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Sintilimab 200 mg IV Every 3 Weeks
n=10 Participants
Participants with unresectable, locally advanced, recurrent or metastatic Cancer of Unknown Primary (CUP)
|
|---|---|
|
Progression-free Survival (PFS)
|
4.4 months
Interval 2.0 to 25.4
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Sintilimab 200 mg IV Every 3 Weeks
n=10 Participants
Participants with unresectable, locally advanced, recurrent or metastatic Cancer of Unknown Primary (CUP)
|
|---|---|
|
Overall Survival (OS)
|
25.4 months
Interval 4.0 to 27.4
|
Adverse Events
Sintilimab 200 mg IV Every 3 Weeks
Serious events: 0 serious events
Other events: 3 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sintilimab 200 mg IV Every 3 Weeks
n=10 participants at risk
Participants with unresectable, locally advanced, recurrent or metastatic Cancer of Unknown Primary (CUP)
|
|---|---|
|
Infections and infestations
Sepsis
|
20.0%
2/10 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
1/10 • 1 year
|
Additional Information
Dr. Kanwal Raghav
The University of Texas MD Anderson Cancer Center
Phone: (917) 733-0356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place