Trial Outcomes & Findings for Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors (NCT NCT02499952)
NCT ID: NCT02499952
Last Updated: 2022-07-11
Results Overview
CBR of single agent pembrolizumab in subjects with refractory germ cell tumors (GCTs), determined by sum of complete responses, partial responses, and stable disease for at least 3 months using Immune Related Response Criteria (irRC). Complete Response(irPR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart. Partial Response (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation. Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
up to 18 weeks
Results posted on
2022-07-11
Participant Flow
Participant milestones
| Measure |
Experimental Arm
Pembrolizumab
Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Experimental Arm
Pembrolizumab
Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
9
|
Baseline Characteristics
Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=12 Participants
Pembrolizumab
Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
38 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
|
Location Of Primary Tumor
Testis
|
11 Participants
n=93 Participants
|
|
Location Of Primary Tumor
Retroperitoneum
|
0 Participants
n=93 Participants
|
|
Location Of Primary Tumor
Mediastinum
|
1 Participants
n=93 Participants
|
|
Tumor Histology
Seminoma
|
0 Participants
n=93 Participants
|
|
Tumor Histology
Nonseminoma
|
12 Participants
n=93 Participants
|
|
Predominant Histology
Choriocarcinoma
|
3 Participants
n=93 Participants
|
|
Predominant Histology
Embryonal carcinoma
|
5 Participants
n=93 Participants
|
|
Predominant Histology
Teratoma
|
1 Participants
n=93 Participants
|
|
Predominant Histology
Yolk sac tumor
|
3 Participants
n=93 Participants
|
|
Number of Previous Chemotherapy Regimens
1
|
1 Participants
n=93 Participants
|
|
Number of Previous Chemotherapy Regimens
2
|
0 Participants
n=93 Participants
|
|
Number of Previous Chemotherapy Regimens
3
|
7 Participants
n=93 Participants
|
|
Number of Previous Chemotherapy Regimens
4
|
2 Participants
n=93 Participants
|
|
Number of Previous Chemotherapy Regimens
5
|
1 Participants
n=93 Participants
|
|
Number of Previous Chemotherapy Regimens
6
|
1 Participants
n=93 Participants
|
|
ECOG Performance Status
ECOG 0
|
5 Participants
n=93 Participants
|
|
ECOG Performance Status
ECOG 1
|
7 Participants
n=93 Participants
|
|
Metastatic Site(s)
Retroperitoneum
|
5 participants
n=93 Participants
|
|
Metastatic Site(s)
Pulmonary
|
9 participants
n=93 Participants
|
|
Metastatic Site(s)
Non Pulmonary Visceral Metastasis
|
5 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 18 weeksCBR of single agent pembrolizumab in subjects with refractory germ cell tumors (GCTs), determined by sum of complete responses, partial responses, and stable disease for at least 3 months using Immune Related Response Criteria (irRC). Complete Response(irPR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart. Partial Response (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation. Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD.
Outcome measures
| Measure |
Experimental Arm
n=12 Participants
Pembrolizumab
Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
0 percentage of participants w/ clinical b
|
SECONDARY outcome
Timeframe: Every week while patient is receiving pembrolizumab, assessed for up to 52 weeksToxicity and tolerability of pembrolizumab in subjects with refractory GCTs. All grade 3 and higher adverse events are reported.
Outcome measures
| Measure |
Experimental Arm
n=12 Participants
Pembrolizumab
Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
|
|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.
Skin and subcutaneous tissue disorders
|
1 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.
Noncardiac chest pain
|
1 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.
Anemia
|
1 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.
Sciatic pain
|
1 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeksPopulation: Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.
ORR of single agent pembrolizumab in subjects with refractory GCTs, determined by sum of complete responses and partial responses for at least 3 months using RECIST 1.1 criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeksPopulation: Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.
Duration of disease response
Outcome measures
Outcome data not reported
Adverse Events
Experimental Arm
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Arm
n=12 participants at risk
Pembrolizumab
Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.3%
1/12 • Number of events 1 • 6 months.
|
Other adverse events
| Measure |
Experimental Arm
n=12 participants at risk
Pembrolizumab
Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
25.0%
3/12 • Number of events 4 • 6 months.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Psychiatric disorders
ANXIETY
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Eye disorders
BLURRED VISION
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
16.7%
2/12 • Number of events 3 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.7%
2/12 • Number of events 2 • 6 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
25.0%
3/12 • Number of events 3 • 6 months.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
16.7%
2/12 • Number of events 2 • 6 months.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
16.7%
2/12 • Number of events 2 • 6 months.
|
|
General disorders
EDEMA LIMBS
|
16.7%
2/12 • Number of events 2 • 6 months.
|
|
General disorders
FATIGUE
|
50.0%
6/12 • Number of events 8 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
16.7%
2/12 • Number of events 2 • 6 months.
|
|
General disorders
FLU LIKE SYMPTOMS
|
16.7%
2/12 • Number of events 2 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Nervous system disorders
HEADACHE
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
8.3%
1/12 • Number of events 2 • 6 months.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL HEMORRHAGE
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER
|
16.7%
2/12 • Number of events 3 • 6 months.
|
|
Gastrointestinal disorders
NAUSEA
|
41.7%
5/12 • Number of events 5 • 6 months.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS
|
8.3%
1/12 • Number of events 2 • 6 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
16.7%
2/12 • Number of events 3 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Eye disorders
PHOTOPHOBIA
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
|
25.0%
3/12 • Number of events 4 • 6 months.
|
|
Skin and subcutaneous tissue disorders
SKIN ATROPHY
|
8.3%
1/12 • Number of events 2 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Ear and labyrinth disorders
TINNITUS
|
8.3%
1/12 • Number of events 1 • 6 months.
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
4/12 • Number of events 6 • 6 months.
|
Additional Information
Clinical Data Coordinator
Hoosier Cancer Research Network
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place