Trial · NCT03132636
PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
NCT03132636, Phase 2, Completed, Regeneron Pharmaceuticals; results first posted 2022-07-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy. Trials, record NCT03132636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03132636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
- NCT number
- NCT03132636
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 138 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Carcinoma, Basal Cell
- Interventions
- cemiplimab
- First posted
- 2017-04-28
- Last updated
- 2025-04-08
- Other registries' IDs
- eudract:2016-003122-16
- Results first posted
- 2022-07-26
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR) | Up to 1422 days (approximately 46 months) | ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 assessed as per ICR assessment. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm) (\< 1 centimeter \[cm\]). PR: At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. ORR was determined by Clopper-Pearson method. |
| Secondary | Objective Response Rate (ORR) Per Investigator Assessment | Up to 1422 days (approximately 46 months) | ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 per Investigator assessment. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm) (\< 1 centimeter \[cm\]). PR: At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. ORR was determined by Clopper-Pearson method. |
| Secondary | Duration of Response (DOR) as Assessed by ICR | Up to 48 months | DOR per ICR was determined for participants with best overall response of CR or PR. DOR was measured from the time measurement criteria are first met for CR/PR (whichever was first recorded) until the first date of recurrent or progressive disease (PD) (photographic or radiographic), or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). DOR was determined by Kaplan-Meier estimate. |
| Secondary | Duration of Response (DOR) Per Investigator Assessment | Up to 48 months | DOR per investigator assessment was determined for participants with best overall response of CR or PR. DOR was measured from the time measurement criteria are first met for CR/PR (whichever was first recorded) until the first date of recurrent or progressive disease (PD) (photographic or radiographic), or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). DOR was determined by Kaplan-Meier estimate. |
| Secondary | Complete Response (CR) Rate as Assessed by ICR | Up to 48 months | CR rate was determined by the percentage of participants with best overall response of CR. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). CR rate 95% confidence interval determined by Clopper-Pearson exact confidence interval. |
| Secondary | Complete Response (CR) Rate Per Investigator Assessment | Up to 48 months | CR rate was determined by the percentage of participants with best overall response of CR. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). CR rate 95% confidence interval determined by Clopper-Pearson exact confidence interval. |
| Secondary | Progression Free Survival (PFS) as Assessed by ICR | Up to 60 months | PFS was defined as the time from start of treatment until the first date of recurrent or PD (photographic or radiographic), or death due to any cause, whichever occurred first, was determined by IRC. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). PFS was determined by Kaplan-Meier estimate. |
| Secondary | Progression Free Survival (PFS) Per Investigator Assessment | Up to 60 months | PFS was defined as the time from start of treatment until the first date of recurrent or PD (photographic or radiographic), or death due to any cause, whichever occurred first, was determined by IRC. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). PFS was determined by Kaplan-Meier estimate. |
| Secondary | Overall Survival (OS) | Up to 60 months | OS was measured as time from the start of treatment until death due to any cause. Participants who did not die were censored at the last date that participant was documented to be alive. OS was calculated based on Kaplan-Meier estimate. |
| Secondary | Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks]) | The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a higher score indicates higher ("better") quality of life/functioning and a positive change from baseline indicates improvement. For the symptom scales/items, a higher score indicates a higher ("worse") level of symptoms/problems, and a negative change from baseline indicates improvement. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR) | Up to 1422 days (approximately 46 months) | Full analysis set (FAS) (included all enrolled participants for each group who passed screening and were deemed to be eligible for this study) | Percentage of Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) Per Investigator Assessment | Up to 1422 days (approximately 46 months) | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by ICR | Up to 48 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, Overall number of participants analyzed signifies those participants with confirmed CR or PR. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Per Investigator Assessment | Up to 48 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, Overall number of participants analyzed signifies those participants with confirmed CR or PR. | Months | MEDIAN |
| SECONDARY | Complete Response (CR) Rate as Assessed by ICR | Up to 48 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Percentage of Participants | NUMBER |
| SECONDARY | Complete Response (CR) Rate Per Investigator Assessment | Up to 48 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Percentage of Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) as Assessed by ICR | Up to 60 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Per Investigator Assessment | Up to 60 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 60 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Months | MEDIAN |
| SECONDARY | Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks]) | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Number analyzed signifies those participants who were evaluable at specific time points. | Score on a Scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group324
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR) | Group 1: Metastatic BCC (mBCC) | 22.2 | 95% Confidence Interval 12.0 to 35.6 | Percentage of Participants | |
| Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR) | Group 2: Unresectable Locally Advanced BCC (laBCC) | 32.1 | 95% Confidence Interval 22.4 to 43.2 | Percentage of Participants | |
| Objective Response Rate (ORR) Per Investigator Assessment | Group 1: Metastatic BCC (mBCC) | 25.9 | 95% Confidence Interval 15.0 to 39.7 | Percentage of Participants | |
| Objective Response Rate (ORR) Per Investigator Assessment | Group 2: Unresectable Locally Advanced BCC (laBCC) | 36.9 | 95% Confidence Interval 26.6 to 48.1 | Percentage of Participants | |
| Duration of Response (DOR) as Assessed by ICR | Group 1: Metastatic BCC (mBCC) | NA | 95% Confidence Interval 9.8 to NA | Months | |
| Duration of Response (DOR) as Assessed by ICR | Group 2: Unresectable Locally Advanced BCC (laBCC) | NA | 95% Confidence Interval 15.5 to NA | Months | |
| Duration of Response (DOR) Per Investigator Assessment | Group 1: Metastatic BCC (mBCC) | NA | 95% Confidence Interval 9.8 to NA | Months | |
| Duration of Response (DOR) Per Investigator Assessment | Group 2: Unresectable Locally Advanced BCC (laBCC) | 19.6 | 95% Confidence Interval 16.7 to NA | Months | |
| Complete Response (CR) Rate as Assessed by ICR | Group 1: Metastatic BCC (mBCC) | 3.7 | 95% Confidence Interval 0.5 to 12.7 | Percentage of Participants | |
| Complete Response (CR) Rate as Assessed by ICR | Group 2: Unresectable Locally Advanced BCC (laBCC) | 8.3 | 95% Confidence Interval 3.4 to 16.4 | Percentage of Participants |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Metastatic BCC (mBCC) | 54 | |
| Overall Study | STARTED | Group 2: Unresectable Locally Advanced BCC (laBCC) | 84 | |
| Overall Study | Completed Treatment | Group 1: Metastatic BCC (mBCC) | 11 | |
| Overall Study | Completed Treatment | Group 2: Unresectable Locally Advanced BCC (laBCC) | 28 | |
| Overall Study | COMPLETED | Group 1: Metastatic BCC (mBCC) | 6 | |
| Overall Study | COMPLETED | Group 2: Unresectable Locally Advanced BCC (laBCC) | 19 | |
| Overall Study | NOT COMPLETED | Group 1: Metastatic BCC (mBCC) | 48 | |
| Overall Study | NOT COMPLETED | Group 2: Unresectable Locally Advanced BCC (laBCC) | 65 |
Source ClinicalTrials.gov
Adverse events276
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Group 1: Metastatic BCC (mBCC) | 6 | 54 | 9 |
| other | Nausea | Gastrointestinal disorders | Group 2: Unresectable Locally Advanced BCC (laBCC) | 13 | 84 | 19 |
| other | Vomiting | Gastrointestinal disorders | Group 1: Metastatic BCC (mBCC) | 7 | 54 | 9 |
| other | Vomiting | Gastrointestinal disorders | Group 2: Unresectable Locally Advanced BCC (laBCC) | 6 | 84 | 10 |
| other | Constipation | Gastrointestinal disorders | Group 1: Metastatic BCC (mBCC) | 12 | 54 | 14 |
| other | Constipation | Gastrointestinal disorders | Group 2: Unresectable Locally Advanced BCC (laBCC) | 5 | 84 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Group 1: Metastatic BCC (mBCC) | 20 | 54 | 26 |
| other | Diarrhoea | Gastrointestinal disorders | Group 2: Unresectable Locally Advanced BCC (laBCC) | 20 | 84 | 33 |
| other | Abdominal pain | Gastrointestinal disorders | Group 1: Metastatic BCC (mBCC) | 4 | 54 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Group 2: Unresectable Locally Advanced BCC (laBCC) | 6 | 84 | 7 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Metastatic BCC (mBCC) | 22 | 54 |
| Total, all-cause mortality | Group 2: Unresectable Locally Advanced BCC (laBCC) | 21 | 84 |
| Total, other adverse events | Group 1: Metastatic BCC (mBCC) | 50 | 54 |
| Total, other adverse events | Group 2: Unresectable Locally Advanced BCC (laBCC) | 76 | 84 |
| Total, serious adverse events | Group 1: Metastatic BCC (mBCC) | 18 | 54 |
| Total, serious adverse events | Group 2: Unresectable Locally Advanced BCC (laBCC) | 33 | 84 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: Metastatic BCC (mBCC) vs Group 2: Unresectable Locally Advanced BCC (laBCC): deaths from any cause | Trial comparisons |
| Group 1: Metastatic BCC (mBCC) vs Group 2: Unresectable Locally Advanced BCC (laBCC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03132636
GET https://conductscience.org/api/trials/v1/NCT03132636/results?page=2