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Trial record 39 of 78 for:    vismodegib

Pembrolizumab With or Without Vismodegib in Treating Metastatic or Unresectable Basal Cell Skin Cancer

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ClinicalTrials.gov Identifier: NCT02690948
Recruitment Status : Completed
First Posted : February 24, 2016
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Anne Chang, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Skin Basal Cell Carcinoma
Interventions Biological: Pembrolizumab
Drug: Vismodegib
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Hide Arm/Group Description

Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Vismodegib: Given PO

Period Title: Overall Study
Started 9 7
Completed 9 7
Not Completed 0 0
Arm/Group Title Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy Total
Hide Arm/Group Description

Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Vismodegib: Given PO

Total of all reporting groups
Overall Number of Baseline Participants 9 7 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 7 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  44.4%
4
  57.1%
8
  50.0%
>=65 years
5
  55.6%
3
  42.9%
8
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 7 participants 16 participants
69.7  (11.2) 61.9  (7.51) 65.1  (9.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 7 participants 16 participants
Female
1
  11.1%
2
  28.6%
3
  18.8%
Male
8
  88.9%
5
  71.4%
13
  81.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 7 participants 16 participants
Hispanic or Latino
3
  33.3%
1
  14.3%
4
  25.0%
Not Hispanic or Latino
6
  66.7%
6
  85.7%
12
  75.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 7 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
7
  77.8%
7
 100.0%
14
  87.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  22.2%
0
   0.0%
2
  12.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 7 participants 16 participants
9 7 16
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description

The overall response rate (ORR) of participants with unresectable or metastatic basal cell carcinoma (BCC) after treatment with A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, will be assessed as the percentage of participants with partial response (PR) or complete response (CR) as determined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria, after 9 and 18 weeks of treatment. ORR is calculated as the ratio of patients with CR or PR as a percentage of the participants evaluable for OR.

RECIST criteria:

  • Complete Response (CR) = Disappearance of all target lesions
  • Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
  • Overall Response (OR) = CR + PR
  • Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
  • Stable disease (SD) = Small changes that do not meet any of the above criteria
Time Frame 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Hide Arm/Group Description:

Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Vismodegib: Given PO

Overall Number of Participants Analyzed 9 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
44
(14 to 79)
29
(4 to 71)
2.Secondary Outcome
Title Percentage of Participants Experiencing Adverse Events
Hide Description Incidence of Adverse Events is assessed as the percentage of participants receiving treatment who experience adverse events of any grade, in participants receiving A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib. Enrolled participants receiving at least one dose of study agent and with at least one follow-up evaluation will be included.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Hide Arm/Group Description:

Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Vismodegib: Given PO

Overall Number of Participants Analyzed 9 7
Measure Type: Number
Unit of Measure: percentage of participants
100 100
3.Secondary Outcome
Title Related Adverse Events
Hide Description Adverse events were assessed for relationship to pembrolizumab treatment. The outcome is reported as the number (without dispersion) of Grade 3 or higher adverse events considered possibly, probably, or definitely-related to pembrolizumab treatment,.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Hide Arm/Group Description:

Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Vismodegib: Given PO

Overall Number of Participants Analyzed 9 7
Measure Type: Number
Unit of Measure: Related adverse events
1 0
4.Secondary Outcome
Title Duration of Response (DOR)
Hide Description

The duration of response (DOR) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria in participants receiving A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, assessed as the median value for subjects who complete 9 and 18 weeks of treatment.

RECIST criteria:

  • Complete Response (CR) = Disappearance of all target lesions
  • Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
  • Overall Response (OR) = CR + PR
  • Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
  • Stable disease (SD) = Small changes that do not meet any of the above criteria
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Hide Arm/Group Description:

Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Vismodegib: Given PO

Overall Number of Participants Analyzed 4 2
Median (Full Range)
Unit of Measure: Weeks
67.57
(31.43 to 82)
52.78
(28 to 77.57)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description The overall survival (OS) participants with unresectable or metastatic basal cell carcinoma (BCC) after treatment with A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, will be reported as the number and percentage of participants remaining alive 1 year after the start of treatment.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Hide Arm/Group Description:

Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Vismodegib: Given PO

Overall Number of Participants Analyzed 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
9
 100.0%
7
 100.0%
6.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description The progression-free survival (PFS) will be participants with unresectable or metastatic basal cell carcinoma (BCC) after treatment with A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, will be reported as the percentage of participants without progression 1 year after the start of treatment.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Hide Arm/Group Description:

Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Vismodegib: Given PO

Overall Number of Participants Analyzed 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
3
  33.3%
1
  14.3%
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Hide Arm/Group Description

Participants who previously received vismodegib and subsequently progressed will receive pembrolizumab IV over 30 minutes on day 1. Cycles are every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Participants who have not progressed while receiving vismodegib will receive pembrolizumab IV over 30 minutes on day 1 and take vismodegib 150 mg by mouth daily. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Pembrolizumab: Given IV

Vismodegib: Given PO

All-Cause Mortality
Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/7 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/9 (33.33%)      2/7 (28.57%)    
Gastrointestinal disorders     
Diarrhea  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Infections and infestations     
Urinary tract infection  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Infections and infestations - Other, Peri-incisional cellulitis  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Surgical and medical procedures     
Surgical and medical procedures - Other, right shoulder four quarter amputation  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Surgical and medical procedures - tumor resection  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Vascular disorders     
Hypertension  1  1/9 (11.11%)  3 0/7 (0.00%)  0
1
Term from vocabulary, CTCAEv4
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pembrolizumab Monotherapy Pembrolizumab Plus Vismodegib Combination Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/9 (100.00%)      7/7 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Blood and lymphatic system disorders-Other, Lymphadenopathy  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Cardiac disorders     
Atrial fibrillation  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Hypertension  1  2/9 (22.22%)  3 1/7 (14.29%)  1
Cardiac disorders - Other, Premature ventricular contraction  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Ear and labyrinth disorders     
External ear inflammation  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Endocrine disorders     
Hypothyroidism  1  2/9 (22.22%)  2 1/7 (14.29%)  1
Eye disorders     
Eye disorders - Other, ptosis  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Conjunctivitis  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Eye disorders - Other, Eye Erosion  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Rectal hemorrhage  1  1/9 (11.11%)  2 0/7 (0.00%)  0
Diarrhea  1  2/9 (22.22%)  2 1/7 (14.29%)  1
Dry mouth  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Nausea  1  3/9 (33.33%)  4 1/7 (14.29%)  1
Tooth loss  1  0/9 (0.00%)  0 1/7 (14.29%)  1
General disorders     
Edema limbs  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Fatigue  1  6/9 (66.67%)  6 3/7 (42.86%)  3
Fever  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Pain  1  4/9 (44.44%)  6 1/7 (14.29%)  1
Infections and infestations     
Bronchitis  1  2/9 (22.22%)  2 0/7 (0.00%)  0
Sinusitis  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Skin infection  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Upper respiratory infection  1  3/9 (33.33%)  3 1/7 (14.29%)  1
Urinary tract infection  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Infections and infestations -Other, Paronychia  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Rhinitis infective  1  1/9 (11.11%)  1 1/7 (14.29%)  2
Injury, poisoning and procedural complications     
Fracture  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Investigations     
Weight loss  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Metabolism and nutrition disorders     
Hyponatremia  1  1/9 (11.11%)  3 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bone Pain  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorder -Other, muscle cramp  1  1/9 (11.11%)  1 3/7 (42.86%)  3
Myalgia  1  2/9 (22.22%)  2 0/7 (0.00%)  0
Arthalgia  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Muscle weakness lower limb  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Musculoskeletal and connective tissue disorder -Other, gout  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Other, Neoplasm Benign  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) -Other, squamous cell carcinoma)  1  2/9 (22.22%)  2 0/7 (0.00%)  0
Nervous system disorders     
Dysgeusia  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Headache  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Paresthesia  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Tremor  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Psychiatric disorders     
Agitation  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Anxiety  1  1/9 (11.11%)  1 1/7 (14.29%)  1
Insomnia  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Renal and urinary disorders     
Urinary frequency  1  0/9 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Dyspnea  1  3/9 (33.33%)  3 2/7 (28.57%)  2
Epistaxis  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders - Other, actinic keratosis  1  2/9 (22.22%)  2 2/7 (28.57%)  3
Alopecia  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Purpura  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Rash  1  4/9 (44.44%)  5 4/7 (57.14%)  4
Pruritis  1  2/9 (22.22%)  2 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, laceration  1  1/9 (11.11%)  1 1/7 (14.29%)  1
Skin and subcutaneous tissue disorders - Other, seborrheic keratosis  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, Verruca  1  2/9 (22.22%)  3 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, psoraisis  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Surgical and medical procedures     
Surgical and medical procedures - Other, Elective Surgery-Foot  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Surgical and medical procedures - Other, Root Canal  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Surgical and medical procedures - Other, Mohs Surgery  1  1/9 (11.11%)  1 0/7 (0.00%)  0
Surgical and medical procedures - Other, Skin tag removal  1  0/9 (0.00%)  0 1/7 (14.29%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Anne Lynn S. Chang, Associate Professor of Dermatology
Organization: Stanford University
Phone: 650-721-7151
Responsible Party: Anne Chang, Stanford University
ClinicalTrials.gov Identifier: NCT02690948     History of Changes
Other Study ID Numbers: IRB-34925
NCI-2015-01869 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
350 ( Other Identifier: NCI )
P30CA124435 ( U.S. NIH Grant/Contract )
SKIN0031 ( Other Identifier: OnCore )
First Submitted: February 12, 2016
First Posted: February 24, 2016
Results First Submitted: January 31, 2019
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019