Trial · NCT02919969

Pembrolizumab in Metastatic Anal Cancer

NCT02919969, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2023-06-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pembrolizumab in Metastatic Anal Cancer. Trials, record NCT02919969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02919969

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pembrolizumab in Metastatic Anal Cancer
NCT number: NCT02919969
Status: Completed
Phases: Phase 2
Enrollment: 38 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Anal Cancer
Interventions: Pembrolizumab
First posted: 2016-09-30
Last updated: 2023-06-12
Results first posted: 2023-06-12

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate	Disease was evaluated radiologically at baseline and every 3 cycles on treatment. The median follow-up was 12.6 months. All registered patients received at least one infusion of pembrolizumab and were treated for a median of 2 months (range: 0-23 months)	Overall response rate of pembrolizumab in metastatic anal cancer patients will be evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions. A 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.
Secondary	PD-L1 Positive Response Rate	36 months	Response rate in PD-L1 positive metastatic anal cancer patients will be evaluated by RECIST 1.1.
Secondary	Overall Survival	36 months	Evaluate the durability of pembrolizumab responses in PD-L1 positive metastatic anal cancer patients by measuring median overall survival.
Secondary	Progression Free Survival	36 months	Evaluate the durability of pembrolizumab responses in PD-L1 positive metastatic anal cancer patients by measuring median progression free survival.
Secondary	Incidence of Adverse Events to Evaluate the Safety and Tolerability of Pembrolizumab	Every 3 Weeks, from the time the informed consent is signed through 90 days following cessation of treatment "Every 3 Weeks, from the time the informed consent is signed through 30 days following cessation of treatment	Assess how well pembrolizumab is tolerated in patients with metastatic anal cancer by evaluating adverse events by CTCAE v4.0. Safety was assessed every 3 Weeks, from the time the informed consent is signed through 90 days following cessation of treatment. The median follow-up period was 12.6 months (range= 0.6-51.6 months).

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate	Disease was evaluated radiologically at baseline and every 3 cycles on treatment. The median follow-up was 12.6 months. All registered patients received at least one infusion of pembrolizumab and were treated for a median of 2 months (range: 0-23 months)	The analysis dataset is comprised of all treated patients.	probability	NUMBER
SECONDARY	PD-L1 Positive Response Rate	36 months		probability	NUMBER
SECONDARY	Overall Survival	36 months		months	MEDIAN
SECONDARY	Progression Free Survival	36 months		months	MEDIAN
SECONDARY	Incidence of Adverse Events to Evaluate the Safety and Tolerability of Pembrolizumab	Every 3 Weeks, from the time the informed consent is signed through 90 days following cessation of treatment Every 3 Weeks, from the time the informed consent is signed through 30 days following cessation of treatment		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Response Rate	Pembrolizumab	11.1	95% Confidence Interval 2.4 to 29.2	probability
PD-L1 Positive Response Rate	Pembrolizumab	13.0	95% Confidence Interval 3.99 to 35.1	probability
Overall Survival	Pembrolizumab	13.6	95% Confidence Interval 6.5 to 17.7	months
Progression Free Survival	Pembrolizumab	2.2	95% Confidence Interval 1.9 to 4.1	months
Incidence of Adverse Events to Evaluate the Safety and Tolerability of Pembrolizumab	Pembrolizumab	25		Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pembrolizumab	32
Overall Study	COMPLETED	Pembrolizumab	1
Overall Study	NOT COMPLETED	Pembrolizumab	31

Source ClinicalTrials.gov

Adverse events55

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	Alanine aminotransferase increased	Investigations	Pembrolizumab	2	32	4
other	Alkaline phosphatase increased	Investigations	Pembrolizumab	2	32	2
other	Anemia	Blood and lymphatic system disorders	Pembrolizumab	2	32	2
other	Anorexia	Metabolism and nutrition disorders	Pembrolizumab	1	32	2
other	Arthralgia	Musculoskeletal and connective tissue disorders	Pembrolizumab	4	32	5
other	Aspartate aminotransferase increased	Investigations	Pembrolizumab	6	32	8
other	Blood bilirubin increased	Investigations	Pembrolizumab	1	32	1
other	Blurred vision	Eye disorders	Pembrolizumab	1	32	1
other	Colitis	Gastrointestinal disorders	Pembrolizumab	1	32	1
other	Constipation	Gastrointestinal disorders	Pembrolizumab	1	32	1

1 to 10 of 55Source ClinicalTrials.gov

See all 55 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pembrolizumab	24	32
Total, other adverse events	Pembrolizumab	24	32
Total, serious adverse events	Pembrolizumab	13	32

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02919969

GET https://conductscience.org/api/trials/v1/NCT02919969/events?page=2

API reference For AI assistants