Trial · NCT02921256

Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer

NCT02921256, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-06-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer. Trials, record NCT02921256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02921256

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Trial

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

Title: Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal Cancer
NCT number: NCT02921256
Status: Completed
Phases: Phase 2
Enrollment: 363 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v7, Stage III Rectal Cancer AJCC v7
Interventions: Capecitabine, Fluorouracil, Intensity-Modulated Radiation Therapy, Leucovorin, Oxaliplatin, Pembrolizumab, Veliparib
First posted: 2016-10-03
Last updated: 2025-12-04
Results first posted: 2023-06-09

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Neoadjuvant Rectal Cancer (NAR) Score	Baseline to up to 3 years	A linear regression model that controls for the stratification factors (cT-stage and cN-stage) will be used. Mean NAR scores along with standard errors and confidence intervals will be reported by treatment. The NAR score ranges from zero to 100 with lower values corresponding to better prognosis.
Secondary	Overall Survival	Time from randomization, assessed up to 3 years	Analyzed using the stratified log rank test with strata cT-stage and cN-stage. Kaplan-Meier plots will illustrate the distribution of these endpoints by treatment. Cox regression models will be used to estimate hazard ratios and associated confidence intervals.
Secondary	Disease Free Survival	Time from randomization, assessed up to 3 years	Analyzed using the stratified log rank test with strata cT-stage and cN-stage. Kaplan-Meier plots will illustrate the distribution of these endpoints by treatment. Cox regression models will be used to estimate hazard ratios and associated confidence intervals.
Secondary	Rate of Pathologic Complete Response (Nodes and Tumor) ypT0 and ypN0	Up to 3 years	Pathologic Complete Response means no remaining cancer detectable in the pathology sample. Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.
Secondary	Rate of Sphincter Preservation	Up to 3 years	Sphincter preservation means that the surgical procedure used to remove the tumor did not disturb the sphincter muscle. Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.
Other	Proportion of Patients Who Have a Tumor Resection Overall (and Conditional on Beginning Induction Chemotherapy, and Conditional on Beginning Chemoradiotherapy)	Up to 3 years	Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.
Other	Time From Initiation of Chemoradiotherapy to Surgery in the Subset of Patients With Tumor Resection	Up to 3 years	Analyzed using the stratified log rank test with strata cT-stage and cN-stage. Kaplan-Meier plots will illustrate the distribution of time to surgery (TTS) by treatment. Cox regression models will be used to estimate hazard ratios and associated confidence intervals.
Other	Rate of Disease Progression During Chemotherapy (Prior to Chemoradiation)	Up to 3 years	Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.
Other	Rate of Clinical Complete Response Rate, ycT0	Up to 3 years	Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.
Other	Rate of Negative Circumferential Margin	Up to 3 years	Analyzed by a logistic regression model that controls for the stratification factors (cT-stage and cN-stage). Observed proportions along with confidence intervals will be presented by treatment.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Neoadjuvant Rectal Cancer (NAR) Score	Baseline to up to 3 years	Patients who had a tumor resection and have pathology o the tumor specimen were evaluable for the primary endpoint of NAR score and included in the analysis.	score on a scale	MEAN
SECONDARY	Overall Survival	Time from randomization, assessed up to 3 years	Participants with follow-up	proportion of participants	NUMBER
SECONDARY	Disease Free Survival	Time from randomization, assessed up to 3 years	Participants with follow-up	proportion of participants	NUMBER
SECONDARY	Rate of Pathologic Complete Response (Nodes and Tumor) ypT0 and ypN0	Up to 3 years		percentage of participants	MEAN
SECONDARY	Rate of Sphincter Preservation	Up to 3 years		percentage of participants	MEAN
OTHER_PRE_SPECIFIED	Proportion of Patients Who Have a Tumor Resection Overall (and Conditional on Beginning Induction Chemotherapy, and Conditional on Beginning Chemoradiotherapy)	Up to 3 years
OTHER_PRE_SPECIFIED	Time From Initiation of Chemoradiotherapy to Surgery in the Subset of Patients With Tumor Resection	Up to 3 years
OTHER_PRE_SPECIFIED	Rate of Disease Progression During Chemotherapy (Prior to Chemoradiation)	Up to 3 years
OTHER_PRE_SPECIFIED	Rate of Clinical Complete Response Rate, ycT0	Up to 3 years
OTHER_PRE_SPECIFIED	Rate of Negative Circumferential Margin	Up to 3 years

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group20

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

Outcome	Group	Value	Spread	Units
Neoadjuvant Rectal Cancer (NAR) Score	Arm Ia (mFOLFOX6, RT, Capecitabine)	12.6	95% Confidence Interval 9.8 to 15.3	score on a scale
Neoadjuvant Rectal Cancer (NAR) Score	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	13.7	95% Confidence Interval 10.2 to 17.2	score on a scale
Neoadjuvant Rectal Cancer (NAR) Score	Arm Ib (mFOLFOX6, RT, Capecitabine)	14.1	95% Confidence Interval 10.7 to 17.4	score on a scale
Neoadjuvant Rectal Cancer (NAR) Score	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	11.5	95% Confidence Interval 8.5 to 14.5	score on a scale
Overall Survival	Arm Ia (mFOLFOX6, RT, Capecitabine)	0.922	95% Confidence Interval 0.834 to 0.964	proportion of participants
Overall Survival	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	0.849	95% Confidence Interval 0.754 to 0.910	proportion of participants
Overall Survival	Arm Ib (mFOLFOX6, RT, Capecitabine)	0.867	95% Confidence Interval 0.772 to 0.924	proportion of participants
Overall Survival	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	0.950	95% Confidence Interval 0.870 to 0.981	proportion of participants
Disease Free Survival	Arm Ia (mFOLFOX6, RT, Capecitabine)	0.675	95% Confidence Interval 0.559 to 0.766	proportion of participants
Disease Free Survival	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	0.600	95% Confidence Interval 0.490 to 0.694	proportion of participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Arm 1a v. Arm II	STARTED	Arm I (mFOLFOX6, RT, Capecitabine)	88
Arm 1a v. Arm II	STARTED	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	90
Arm 1a v. Arm II	STARTED	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	0
Arm 1a v. Arm II	COMPLETED	Arm I (mFOLFOX6, RT, Capecitabine)	72
Arm 1a v. Arm II	COMPLETED	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	57
Arm 1a v. Arm II	COMPLETED	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	0
Arm 1a v. Arm II	NOT COMPLETED	Arm I (mFOLFOX6, RT, Capecitabine)	16
Arm 1a v. Arm II	NOT COMPLETED	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	33
Arm 1a v. Arm II	NOT COMPLETED	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	0
Arm Ib v Arm III	STARTED	Arm I (mFOLFOX6, RT, Capecitabine)	95

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events524

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
other	Abdominal pain	Gastrointestinal disorders	Arm Ia (mFOLFOX6, RT, Capecitabine)	10	83
other	Abdominal pain	Gastrointestinal disorders	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	21	88
other	Abdominal pain	Gastrointestinal disorders	Arm Ib (mFOLFOX6, RT, Capecitabine)	7	84
other	Abdominal pain	Gastrointestinal disorders	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	6	82
other	Alanine aminotransferase increased	Investigations	Arm Ia (mFOLFOX6, RT, Capecitabine)	2	83
other	Alanine aminotransferase increased	Investigations	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	5	88
other	Alanine aminotransferase increased	Investigations	Arm Ib (mFOLFOX6, RT, Capecitabine)	10	84
other	Alanine aminotransferase increased	Investigations	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	8	82
other	Anal pain	Gastrointestinal disorders	Arm Ia (mFOLFOX6, RT, Capecitabine)	12	83
other	Anal pain	Gastrointestinal disorders	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	19	88

1 to 10 of 524Source ClinicalTrials.gov

See all 524 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm Ia (mFOLFOX6, RT, Capecitabine)	7	87
Total, all-cause mortality	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	14	90
Total, all-cause mortality	Arm Ib (mFOLFOX6, RT, Capecitabine)	13	93
Total, all-cause mortality	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	6	87
Total, other adverse events	Arm Ia (mFOLFOX6, RT, Capecitabine)	83	83
Total, other adverse events	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	86	88
Total, other adverse events	Arm Ib (mFOLFOX6, RT, Capecitabine)	82	84
Total, other adverse events	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	81	82
Total, serious adverse events	Arm Ia (mFOLFOX6, RT, Capecitabine)	16	83
Total, serious adverse events	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	25	88

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34196693	DERIVED	PubMed
37478389	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA180868	NRG Oncology Network Group Operations Center	WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S.	NRG ONCOLOGY FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

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/NCT02921256

GET https://conductscience.org/api/trials/v1/NCT02921256/events?page=2

API reference For AI assistants