Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors

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ClinicalTrials.gov Identifier: NCT02499952

Recruitment Status : Terminated (Lack of Efficacy)

First Posted : July 16, 2015

Results First Posted : April 17, 2018

Last Update Posted : July 11, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Hoosier Cancer Research Network

Merck Sharp & Dohme LLC

Information provided by (Responsible Party):

Nasser Hanna, M.D., Hoosier Cancer Research Network

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Germ Cell Neoplasms Testicular Neoplasms Non Seminomatous Germ Cell Tumors Mediastinal Neoplasms Genital Neoplasms, Male Genital Neoplasms, Female Ovarian Neoplasms
Intervention	Drug: Pembrolizumab
Enrollment	12

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Experimental Arm
Arm/Group Description	Pembrolizumab ...
Arm/Group Description	Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
Period Title: Overall Study
Started	12
Completed	2
Not Completed	10
Reason Not Completed
Lost to Follow-up	1
Death	9

Baseline Characteristics

Arm/Group Title		Experimental Arm
Arm/Group Description		Pembrolizumab ...
Arm/Group Description		Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
Overall Number of Baseline Participants		12
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	12 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	12 100.0%
	>=65 years	0 0.0%
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	12 participants
		38 (27 to 55)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	12 participants
	Female	0 0.0%
	Male	12 100.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	12 participants
	Hispanic or Latino	0 0.0%
	Not Hispanic or Latino	12 100.0%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	12 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	1 8.3%
	White	11 91.7%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	12 participants
United States		12
Location Of Primary Tumor Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	12 participants
	Testis	11 91.7%
	Retroperitoneum	0 0.0%
	Mediastinum	1 8.3%
Tumor Histology Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	12 participants
	Seminoma	0 0.0%
	Nonseminoma	12 100.0%
Predominant Histology Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	12 participants
	Choriocarcinoma	3 25.0%
	Embryonal carcinoma	5 41.7%
	Teratoma	1 8.3%
	Yolk sac tumor	3 25.0%
Number of Previous Chemotherapy Regimens Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	12 participants
1		1 8.3%
2		0 0.0%
3		7 58.3%
4		2 16.7%
5		1 8.3%
6		1 8.3%
ECOG Performance Status ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	12 participants
	ECOG 0	5 41.7%
	ECOG 1	7 58.3%
		[1] Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead
Metastatic Site(s) ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	12 participants
Retroperitoneum		5
Pulmonary		9
Non Pulmonary Visceral Metastasis		5
		[1] Measure Description: The overall count of metastatic location(s). Subjects may have metastasis at multiple locations.

Outcome Measures

1.Primary Outcome


Title	Clinical Benefit Rate (CBR)
Description	CBR of single agent pembrolizumab in subjects with refractory germ cel...
Description	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.
Time Frame	up to 18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Experimental Arm
Arm/Group Description:	Pembrolizumab ...
Arm/Group Description:	Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
Overall Number of Participants Analyzed	12
Measure Type: Number Unit of Measure: percentage of participants w/ clinical b
	0

2.Secondary Outcome


Title	Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.
Description	Toxicity and tolerability of pembrolizumab in subjects with refractory...
Description	Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs. All grade 3 and higher adverse events are reported.
Time Frame	Every week while patient is receiving pembrolizumab, assessed for up to 52 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Experimental Arm
Arm/Group Description:	Pembrolizumab ...
Arm/Group Description:	Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
Overall Number of Participants Analyzed	12
Measure Type: Count of Participants Unit of Measure: Participants
Skin and subcutaneous tissue disorders	1 8.3%
Noncardiac chest pain	1 8.3%
Anemia	1 8.3%
Sciatic pain	1 8.3%

3.Secondary Outcome


Title	Disease Assessment for Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Criteria
Description	ORR of single agent pembrolizumab in subjects with refractory GCTs, de...
Description	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
Time Frame	From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks

Outcome Measure Data

Analysis Population Description

Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.


Arm/Group Title	Experimental Arm
Arm/Group Description:	Pembrolizumab ...
Arm/Group Description:	Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

4.Secondary Outcome


Title	Disease Assessment for Duration of Disease Response
Description	Duration of disease response
Description	Duration of disease response
Time Frame	From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks

Outcome Measure Data

Analysis Population Description

Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.


Arm/Group Title	Experimental Arm
Arm/Group Description:	Pembrolizumab ...
Arm/Group Description:	Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	6 months.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Experimental Arm
Arm/Group Description	Pembrolizumab ...
Arm/Group Description	Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
All-Cause Mortality
	Experimental Arm
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events Serious Adverse Events
	Experimental Arm
	Affected / at Risk (%)	# Events
Total	2/12 (16.67%)
Blood and lymphatic system disorders
ANEMIA ^* 1	1/12 (8.33%)	1
Musculoskeletal and connective tissue disorders
BACK PAIN ^* 1	1/12 (8.33%)	1
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, CTCAEv4
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Experimental Arm
	Affected / at Risk (%)	# Events
Total	11/12 (91.67%)
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS ^* 1	1/12 (8.33%)	1
Cardiac disorders
ATRIAL FIBRILLATION ^* 1	1/12 (8.33%)	1
Ear and labyrinth disorders
TINNITUS ^* 1	1/12 (8.33%)	1
Endocrine disorders
HYPOTHYROIDISM ^* 1	1/12 (8.33%)	1
Eye disorders
BLURRED VISION ^* 1	1/12 (8.33%)	1
PHOTOPHOBIA ^* 1	1/12 (8.33%)	1
Gastrointestinal disorders
ABDOMINAL PAIN ^* 1	3/12 (25.00%)	4
CONSTIPATION ^* 1	2/12 (16.67%)	3
DIARRHEA ^* 1	3/12 (25.00%)	3
DYSPHAGIA ^* 1	1/12 (8.33%)	1
NAUSEA ^* 1	5/12 (41.67%)	5
VOMITING ^* 1	4/12 (33.33%)	6
General disorders
EDEMA LIMBS ^* 1	2/12 (16.67%)	2
FATIGUE ^* 1	6/12 (50.00%)	8
FLU LIKE SYMPTOMS ^* 1	2/12 (16.67%)	2
NON-CARDIAC CHEST PAIN ^* 1	2/12 (16.67%)	3
Metabolism and nutrition disorders
ANOREXIA ^* 1	1/12 (8.33%)	1
HYPERCALCEMIA ^* 1	1/12 (8.33%)	1
HYPERGLYCEMIA ^* 1	1/12 (8.33%)	2
HYPOPHOSPHATEMIA ^* 1	1/12 (8.33%)	1
Musculoskeletal and connective tissue disorders
BACK PAIN ^* 1	1/12 (8.33%)	1
CHEST WALL PAIN ^* 1	1/12 (8.33%)	1
FLANK PAIN ^* 1	2/12 (16.67%)	2
GENERALIZED MUSCLE WEAKNESS ^* 1	1/12 (8.33%)	1
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER ^* 1	2/12 (16.67%)	3
PAIN IN EXTREMITY ^* 1	1/12 (8.33%)	1
Nervous system disorders
HEADACHE ^* 1	1/12 (8.33%)	1
NERVOUS SYSTEM DISORDERS ^* 1	1/12 (8.33%)	2
Psychiatric disorders
ANXIETY ^* 1	1/12 (8.33%)	1
Renal and urinary disorders
ACUTE KIDNEY INJURY ^* 1	1/12 (8.33%)	1
Reproductive system and breast disorders
PELVIC PAIN ^* 1	1/12 (8.33%)	1
Respiratory, thoracic and mediastinal disorders
COUGH ^* 1	2/12 (16.67%)	2
DYSPNEA ^* 1	2/12 (16.67%)	2
LARYNGEAL HEMORRHAGE ^* 1	1/12 (8.33%)	1
SORE THROAT ^* 1	1/12 (8.33%)	1
Skin and subcutaneous tissue disorders
DRY SKIN ^* 1	2/12 (16.67%)	2
HYPERHIDROSIS ^* 1	1/12 (8.33%)	1
PRURITUS ^* 1	1/12 (8.33%)	1
RASH MACULO-PAPULAR ^* 1	1/12 (8.33%)	1
SKIN AND SUBCUTANEOUS TISSUE DISORDERS ^* 1	3/12 (25.00%)	4
SKIN ATROPHY ^* 1	1/12 (8.33%)	2
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, CTCAEv4

Limitations and Caveats

This study was terminated early due to not meeting the primary efficacy endpoint at a pre-planned interim analysis.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Clinical Data Coordinator
Organization:	Hoosier Cancer Research Network
Phone:	317-921-2050
EMail:	jsmith@hoosiercancer.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Adra N, Einhorn LH, Althouse SK, Ammakkanavar NR, Musapatika D, Albany C, Vaughn D, Hanna NH. Phase II trial of pembrolizumab in patients with platinum refractory germ-cell tumors: a Hoosier Cancer Research Network Study GU14-206. Ann Oncol. 2018 Jan 1;29(1):209-214. doi: 10.1093/annonc/mdx680.

Layout table for additonal information

Responsible Party:	Nasser Hanna, M.D., Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:	NCT02499952
Other Study ID Numbers:	HCRN GU14-206
First Submitted:	July 8, 2015
First Posted:	July 16, 2015
Results First Submitted:	January 30, 2018
Results First Posted:	April 17, 2018
Last Update Posted:	July 11, 2022

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