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

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ClinicalTrials.gov Identifier: NCT02921256

Recruitment Status : Completed

First Posted : October 3, 2016

Results First Posted : June 9, 2023

Last Update Posted : April 24, 2024

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Sponsor:

Collaborator:

NRG Oncology

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Rectal Adenocarcinoma Stage II Rectal Cancer AJCC v7 Stage III Rectal Cancer AJCC v7
Interventions	Drug: Capecitabine Drug: Fluorouracil Radiation: Intensity-Modulated Radiation Therapy Drug: Leucovorin Drug: Oxaliplatin Biological: Pembrolizumab Drug: Veliparib
Enrollment	363

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm I (mFOLFOX6, RT, Capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
Arm/Group Description	Patients receive mFOLFOX6 regimen c...	Patients receive mFOLFOX6 regimen c...	ARM III: Patients receive mFOLFOX6 ...
Arm/Group Description	Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Participants assigned to Arm I concurrently with Arm II are described as Arm Ia and participants assigned to Arm I concurrently with Arm III are described as Arm Ib. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab: Given IV
Period Title: Arm 1a v. Arm II
Started	88	90	0
Completed	72	57	0
Not Completed	16	33	0
Reason Not Completed
Adverse Event	6	15	0
Death	0	2	0
Lack of Efficacy	2	0	0
Lost to Follow-up	2	9	0
Physician Decision	1	1	0
Withdrawal by Subject	5	6	0
Period Title: Arm Ib v Arm III
Started	95	0	90
Completed	71	0	75
Not Completed	24	0	15
Reason Not Completed
Adverse Event	9	0	4
Death	1	0	1
Lack of Efficacy	2	0	2
Lost to Follow-up	1	0	3
Physician Decision	4	0	1
Withdrawal by Subject	7	0	4

Baseline Characteristics

Arm/Group Title		Arm Ia (mFOLFOX6, RT, Capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	Arm Ib (mFOLFOX6, RT, Capecitabine)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	Total
Arm/Group Description		Participants assigned to active com...	Patients receive mFOLFOX6 regimen c...	Participants assigned to active com...	ARM III: Patients receive mFOLFOX6 ...	Total of all reporting groups
Arm/Group Description		Participants assigned to active comparator arm concurrent to Arm II.Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Participants assigned to active comparator arm concurrent to Arm III. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab: Given IV	Total of all reporting groups
Overall Number of Baseline Participants		88	90	95	90	363
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	88 participants	90 participants	95 participants	90 participants	363 participants
		55.5 (10.9)	56.0 (9.8)	55.7 (11.2)	55.5 (11.1)	55.6 (10.7)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	88 participants	90 participants	95 participants	90 participants	363 participants
	Female	29 33.0%	29 32.2%	29 30.5%	30 33.3%	117 32.2%
	Male	59 67.0%	61 67.8%	66 69.5%	60 66.7%	246 67.8%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	88 participants	90 participants	95 participants	90 participants	363 participants
	Hispanic or Latino	3 3.4%	1 1.1%	5 5.3%	9 10.0%	18 5.0%
	Not Hispanic or Latino	84 95.5%	86 95.6%	83 87.4%	78 86.7%	331 91.2%
	Unknown or Not Reported	1 1.1%	3 3.3%	7 7.4%	3 3.3%	14 3.9%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	88 participants	90 participants	95 participants	90 participants	363 participants
	American Indian or Alaska Native	1 1.1%	0 0.0%	2 2.1%	1 1.1%	4 1.1%
	Asian	2 2.3%	8 8.9%	4 4.2%	3 3.3%	17 4.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 1.1%	0 0.0%	0 0.0%	1 0.3%
	Black or African American	4 4.5%	7 7.8%	6 6.3%	2 2.2%	19 5.2%
	White	76 86.4%	71 78.9%	77 81.1%	77 85.6%	301 82.9%
	More than one race	0 0.0%	0 0.0%	0 0.0%	1 1.1%	1 0.3%
	Unknown or Not Reported	5 5.7%	3 3.3%	6 6.3%	6 6.7%	20 5.5%

Outcome Measures

1.Primary Outcome


Title	Neoadjuvant Rectal Cancer (NAR) Score
Description	A linear regression model that controls for the stratification factors...
Description	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.
Time Frame	Baseline to up to 3 years

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Arm Ia (mFOLFOX6, RT, Capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	Arm Ib (mFOLFOX6, RT, Capecitabine)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
Arm/Group Description:	Participants assigned to active com...	Patients receive mFOLFOX6 regimen c...	Participants assigned to active com...	ARM III: Patients receive mFOLFOX6 ...
Arm/Group Description:	Participants assigned to active comparator arm concurrent to Arm II. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Participants assigned to active comparator arm concurrent to ARM III. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV	ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last dose of mFOLFOX6 patient undergoes RT and receives capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab:Given IV
Overall Number of Participants Analyzed	72	68	68	69
Mean (95% Confidence Interval) Unit of Measure: score on a scale
	12.6 (9.8 to 15.3)	13.7 (10.2 to 17.2)	14.1 (10.7 to 17.4)	11.5 (8.5 to 14.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Ia (mFOLFOX6, RT, Capecitabine), Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.69
	Comments	[Not Specified]
	Method	Regression, Linear
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm Ib (mFOLFOX6, RT, Capecitabine), Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.26
	Comments	[Not Specified]
	Method	Regression, Linear
	Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival
Description	Analyzed using the stratified log rank test with strata cT-stage and c...
Description	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.
Time Frame	Time from start of study treatment, assessed up to 3 years

Outcome Measure Data Not Reported

3.Secondary Outcome


Title	Disease Free Survival
Description	Analyzed using the stratified log rank test with strata cT-stage and c...
Description	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.
Time Frame	Time from start of study treatment, assessed up to 3 years

Outcome Measure Data Not Reported

4.Secondary Outcome


Title	Rate of Pathologic Complete Response (Nodes and Tumor) ypT0 and ypN0
Description	Pathologic Complete Response means no remaining cancer detectable in t...
Description	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.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm Ia (mFOLFOX6, RT, Capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	Arm Ib (mFOLFOX6, RT, Capecitabine)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
Arm/Group Description:	Participants assigned to active com...	Patients receive mFOLFOX6 regimen c...	Participants assigned to active com...	ARM III: Patients receive mFOLFOX6 ...
Arm/Group Description:	Participants assigned to active comparator arm concurrent to Arm II. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV	Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID and veliparib PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Veliparib: Given PO	Participants assigned to active comparator arm concurrent to ARM III. Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last does of mFOLFOX6 patient undergo RT and receive capecitabine PO BID Monday-Friday for 5 weeks in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV	ARM III: Patients receive mFOLFOX6 regimen consisting of oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. 3-4 weeks after last dose of mFOLFOX6 patient undergoes RT and receives capecitabine PO BID Monday-Friday for 5 weeks. They also receive pembrolizumab IV over 30 minutes every 3 weeks beginning on day 1 of RT for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Fluorouracil: Given IV Intensity-Modulated Radiation Therapy: Undergo intensity modulated radiation therapy Leucovorin: Given IV Oxaliplatin: Given IV Pembrolizumab:Given IV
Overall Number of Participants Analyzed	74	71	68	69
Mean (95% Confidence Interval) Unit of Measure: percentage of participants
	21.6 (12.9 to 32.7)	33.8 (23.0 to 46.0)	29.4 (19.0 to 41.7)	31.9 (21.2 to 44.2)

5.Secondary Outcome


Title	Rate of Sphincter Preservation
Description	Sphincter preservation means that the surgical procedure used to remov...
Description	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.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm Ia (mFOLFOX6, RT, Capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	Arm Ib (mFOLFOX6, RT, Capecitabine, Pembrolizumab)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
Arm/Group Description:	Arm Ia (mFOLFOX6, RT, capecitabine)	Arm II (mFOLFOX6, RT, capecitabine,...	Arm Ib (mFOLFOX6, RT, capecitabine)	Arm III (mFOLFOX6, RT, capecitabine...
Arm/Group Description:	Arm Ia (mFOLFOX6, RT, capecitabine)	Arm II (mFOLFOX6, RT, capecitabine, veliparib)	Arm Ib (mFOLFOX6, RT, capecitabine)	Arm III (mFOLFOX6, RT, capecitabine, pembrolizumab)
Overall Number of Participants Analyzed	80	81	69	69
Mean (95% Confidence Interval) Unit of Measure: percentage of participants
	52.5 (41.0 to 63.8)	59.3 (47.8 to 70.1)	71.0 (58.8 to 81.3)	59.4 (46.9 to 71.1)

6.Other Pre-specified Outcome


Title	Proportion of Patients Who Have a Tumor Resection Overall (and Conditional on Beginning Induction Chemotherapy, and Conditional on Beginning Chemoradiotherapy)
Description	Analyzed by a logistic regression model that controls for the stratifi...
Description	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.
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

7.Other Pre-specified Outcome


Title	Time From Initiation of Chemoradiotherapy to Surgery in the Subset of Patients With Tumor Resection
Description	Analyzed using the stratified log rank test with strata cT-stage and c...
Description	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.
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

8.Other Pre-specified Outcome


Title	Rate of Disease Progression During Chemotherapy (Prior to Chemoradiation)
Description	Analyzed by a logistic regression model that controls for the stratifi...
Description	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.
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

9.Other Pre-specified Outcome


Title	Rate of Clinical Complete Response Rate, ycT0
Description	Analyzed by a logistic regression model that controls for the stratifi...
Description	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.
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

10.Other Pre-specified Outcome


Title	Rate of Negative Circumferential Margin
Description	Analyzed by a logistic regression model that controls for the stratifi...
Description	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.
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

11.Other Pre-specified Outcome


Title	Rate of Completion of All Cycles of Neoadjuvant Chemotherapy
Description	Analyzed by a logistic regression model that controls for the stratifi...
Description	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.
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

12.Other Pre-specified Outcome


Title	Rate of Completion of Full Course of Chemoradiation
Description	Analyzed by a logistic regression model that controls for the stratifi...
Description	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.
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

13.Other Pre-specified Outcome


Title	Incidence of Toxicity Including Patient-reported Toxicities
Description	Will be assessed using Common Terminology for Adverse Events (CTCAE) v...
Description	Will be assessed using Common Terminology for Adverse Events (CTCAE) version 4.0 (CTCAE version 5.0 beginning April 1, 2018).
Time Frame	30 days after last study treatment

Outcome Measure Data Not Reported

14.Other Pre-specified Outcome


Title	Correlative Molecular Predictors of Response and Distant Failure
Description	Cox regression models will be used to evaluate markers for time-to-eve...
Description	Cox regression models will be used to evaluate markers for time-to-event variables. Logistic regression models will be used for binary variables. Models will control for stratification factors and possibly other prognostic variables (e.g. gender or treatment).
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

15.Other Pre-specified Outcome


Title	Relationship Between Radiographic Findings and Pathologic Outcomes
Description	Will explore the relationship between radiographic findings and pathol...
Description	Will explore the relationship between radiographic findings and pathologic outcomes.
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

Adverse Events

Time Frame	From study entry to surgery, about 7 months.
Adverse Event Reporting Description	Participants at Risk includes any patient who submitted an AE form. Not all participants returned Adverse Event forms; therefore, the Number of Participants At Risk differs between All-Cause Mortality and Serious/Other Adverse Events.

Arm/Group Title	Arm Ia (mFOLFOX6, RT, Capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	Arm Ib (mFOLFOX6, RT, Capecitabine)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
Arm/Group Description	Arm Ia (mFOLFOX6, RT, capecitabine)	Arm II (mFOLFOX6, RT, capecitabine,...	Arm Ib (mFOLFOX6, RT, capecitabine)	Arm Ib (mFOLFOX6, RT, capecitabine,...
Arm/Group Description	Arm Ia (mFOLFOX6, RT, capecitabine)	Arm II (mFOLFOX6, RT, capecitabine, veliparib)	Arm Ib (mFOLFOX6, RT, capecitabine)	Arm Ib (mFOLFOX6, RT, capecitabine, pembrolizumab)
All-Cause Mortality
	Arm Ia (mFOLFOX6, RT, Capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	Arm Ib (mFOLFOX6, RT, Capecitabine)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	7/87 (8.05%)	14/90 (15.56%)	13/93 (13.98%)	6/87 (6.90%)
Serious Adverse Events Serious Adverse Events
	Arm Ia (mFOLFOX6, RT, Capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	Arm Ib (mFOLFOX6, RT, Capecitabine)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	16/83 (19.28%)	25/88 (28.41%)	21/84 (25.00%)	15/82 (18.29%)
Blood and lymphatic system disorders
Anemia ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Febrile neutropenia ^† 1	1/83 (1.20%)	1/88 (1.14%)	2/84 (2.38%)	0/82 (0.00%)
Cardiac disorders
Atrial fibrillation ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Cardiac arrest ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Myocardial infarction ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Sinus tachycardia ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Supraventricular tachycardia ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Endocrine disorders
Hypothyroidism ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	1/83 (1.20%)	2/88 (2.27%)	0/84 (0.00%)	1/82 (1.22%)
Colitis ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	1/82 (1.22%)
Colonic obstruction ^† 1	1/83 (1.20%)	3/88 (3.41%)	1/84 (1.19%)	1/82 (1.22%)
Colonic perforation ^† 1	0/83 (0.00%)	0/88 (0.00%)	0/84 (0.00%)	1/82 (1.22%)
Constipation ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Diarrhea ^† 1	0/83 (0.00%)	7/88 (7.95%)	1/84 (1.19%)	1/82 (1.22%)
Dyspepsia ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Enterocolitis ^† 1	0/83 (0.00%)	2/88 (2.27%)	1/84 (1.19%)	1/82 (1.22%)
Ileus ^† 1	1/83 (1.20%)	0/88 (0.00%)	3/84 (3.57%)	0/82 (0.00%)
Nausea ^† 1	0/83 (0.00%)	1/88 (1.14%)	1/84 (1.19%)	1/82 (1.22%)
Rectal fistula ^† 1	0/83 (0.00%)	0/88 (0.00%)	0/84 (0.00%)	1/82 (1.22%)
Rectal hemorrhage ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Rectal pain ^† 1	0/83 (0.00%)	2/88 (2.27%)	0/84 (0.00%)	1/82 (1.22%)
Small intestinal obstruction ^† 1	0/83 (0.00%)	1/88 (1.14%)	1/84 (1.19%)	0/82 (0.00%)
Vomiting ^† 1	0/83 (0.00%)	1/88 (1.14%)	2/84 (2.38%)	1/82 (1.22%)
Lower gastrointestinal hemorrhage ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Rectal obstruction ^† 1	0/83 (0.00%)	0/88 (0.00%)	0/84 (0.00%)	1/82 (1.22%)
General disorders
Fatigue ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Fever ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	1/82 (1.22%)
Non-cardiac chest pain ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Immune system disorders
Anaphylaxis ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	1/82 (1.22%)
Infections and infestations
Catheter related infection ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Infections and infestations - Other, specify ^† 1	1/83 (1.20%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Sepsis ^† 1	0/83 (0.00%)	1/88 (1.14%)	1/84 (1.19%)	3/82 (3.66%)
Skin infection ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	1/82 (1.22%)
Urinary tract infection ^† 1	0/83 (0.00%)	2/88 (2.27%)	0/84 (0.00%)	1/82 (1.22%)
Pelvic infection ^† 1	0/83 (0.00%)	1/88 (1.14%)	1/84 (1.19%)	0/82 (0.00%)
Enterocolitis infectious ^† 1	1/83 (1.20%)	2/88 (2.27%)	0/84 (0.00%)	1/82 (1.22%)
Lung infection ^† 1	0/83 (0.00%)	1/88 (1.14%)	4/84 (4.76%)	0/82 (0.00%)
Anorectal infection ^† 1	1/83 (1.20%)	1/88 (1.14%)	2/84 (2.38%)	0/82 (0.00%)
Small intestine infection ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Injury, poisoning and procedural complications
Hip fracture ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Wound dehiscence ^† 1	0/83 (0.00%)	0/88 (0.00%)	0/84 (0.00%)	1/82 (1.22%)
Infusion related reaction ^† 1	1/83 (1.20%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Dermatitis radiation ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Rectal anastomotic leak ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Investigations
Activated partial thromboplastin time prolonged ^† 1	0/83 (0.00%)	0/88 (0.00%)	0/84 (0.00%)	1/82 (1.22%)
Alanine aminotransferase increased ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Aspartate aminotransferase increased ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Platelet count decreased ^† 1	0/83 (0.00%)	0/88 (0.00%)	0/84 (0.00%)	1/82 (1.22%)
Metabolism and nutrition disorders
Anorexia ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Dehydration ^† 1	1/83 (1.20%)	4/88 (4.55%)	1/84 (1.19%)	0/82 (0.00%)
Hyperglycemia ^† 1	0/83 (0.00%)	0/88 (0.00%)	2/84 (2.38%)	0/82 (0.00%)
Hypocalcemia ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Hypokalemia ^† 1	0/83 (0.00%)	6/88 (6.82%)	1/84 (1.19%)	2/82 (2.44%)
Hyponatremia ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	2/82 (2.44%)
Hypophosphatemia ^† 1	0/83 (0.00%)	2/88 (2.27%)	1/84 (1.19%)	0/82 (0.00%)
Metabolism and nutrition disorders - Other, specify ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Musculoskeletal and connective tissue disorders
Chest wall pain ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Muscle weakness lower limb ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Nervous system disorders
Encephalopathy ^† 1	0/83 (0.00%)	0/88 (0.00%)	0/84 (0.00%)	1/82 (1.22%)
Intracranial hemorrhage ^† 1	0/83 (0.00%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Peripheral sensory neuropathy ^† 1	0/83 (0.00%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Seizure ^† 1	0/83 (0.00%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Stroke ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Syncope ^† 1	1/83 (1.20%)	2/88 (2.27%)	0/84 (0.00%)	0/82 (0.00%)
Psychiatric disorders
Anxiety ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Delusions ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Suicide attempt ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Renal and urinary disorders
Renal calculi ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Urinary tract obstruction ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Acute kidney injury ^† 1	1/83 (1.20%)	1/88 (1.14%)	0/84 (0.00%)	1/82 (1.22%)
Respiratory, thoracic and mediastinal disorders
Aspiration ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Dyspnea ^† 1	0/83 (0.00%)	0/88 (0.00%)	1/84 (1.19%)	0/82 (0.00%)
Hypoxia ^† 1	1/83 (1.20%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Pneumothorax ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Respiratory failure ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Laryngopharyngeal dysesthesia ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Skin and subcutaneous tissue disorders
Skin ulceration ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Vascular disorders
Hypertension ^† 1	0/83 (0.00%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Hypotension ^† 1	1/83 (1.20%)	1/88 (1.14%)	0/84 (0.00%)	0/82 (0.00%)
Superior vena cava syndrome ^† 1	1/83 (1.20%)	0/88 (0.00%)	0/84 (0.00%)	0/82 (0.00%)
Thromboembolic event ^† 1	3/83 (3.61%)	1/88 (1.14%)	3/84 (3.57%)	2/82 (2.44%)
1 Term from vocabulary, CTCAE v5.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Arm Ia (mFOLFOX6, RT, Capecitabine)	Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)	Arm Ib (mFOLFOX6, RT, Capecitabine)	Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	83/83 (100.00%)	86/88 (97.73%)	82/84 (97.62%)	81/82 (98.78%)
Blood and lymphatic system disorders
Anemia ^† 1	11/83 (13.25%)	18/88 (20.45%)	13/84 (15.48%)	14/82 (17.07%)
Endocrine disorders
Hyperthyroidism ^† 1	0/83 (0.00%)	0/88 (0.00%)	6/84 (7.14%)	0/82 (0.00%)
Hypothyroidism ^† 1	0/83 (0.00%)	0/88 (0.00%)	9/84 (10.71%)	1/82 (1.22%)
Gastrointestinal disorders
Abdominal pain ^† 1	10/83 (12.05%)	21/88 (23.86%)	7/84 (8.33%)	6/82 (7.32%)
Anal pain ^† 1	12/83 (14.46%)	19/88 (21.59%)	2/84 (2.38%)	6/82 (7.32%)
Constipation ^† 1	13/83 (15.66%)	13/88 (14.77%)	13/84 (15.48%)	10/82 (12.20%)
Diarrhea ^† 1	30/83 (36.14%)	43/88 (48.86%)	29/84 (34.52%)	25/82 (30.49%)
Gastrointestinal disorders - Other, specify ^† 1	3/83 (3.61%)	5/88 (5.68%)	0/84 (0.00%)	3/82 (3.66%)
Mucositis oral ^† 1	10/83 (12.05%)	11/88 (12.50%)	4/84 (4.76%)	7/82 (8.54%)
Nausea ^† 1	21/83 (25.30%)	34/88 (38.64%)	24/84 (28.57%)	19/82 (23.17%)
Proctitis ^† 1	6/83 (7.23%)	8/88 (9.09%)	6/84 (7.14%)	7/82 (8.54%)
Rectal pain ^† 1	7/83 (8.43%)	13/88 (14.77%)	16/84 (19.05%)	12/82 (14.63%)
Vomiting ^† 1	8/83 (9.64%)	14/88 (15.91%)	13/84 (15.48%)	3/82 (3.66%)
Rectal mucositis ^† 1	4/83 (4.82%)	8/88 (9.09%)	0/84 (0.00%)	1/82 (1.22%)
Gastroesophageal reflux disease ^† 1	3/83 (3.61%)	3/88 (3.41%)	6/84 (7.14%)	3/82 (3.66%)
General disorders
Fatigue ^† 1	26/83 (31.33%)	46/88 (52.27%)	33/84 (39.29%)	32/82 (39.02%)
Pain ^† 1	5/83 (6.02%)	2/88 (2.27%)	6/84 (7.14%)	4/82 (4.88%)
Infections and infestations
Infections and infestations - Other, specify ^† 1	3/83 (3.61%)	1/88 (1.14%)	5/84 (5.95%)	4/82 (4.88%)
Urinary tract infection ^† 1	3/83 (3.61%)	5/88 (5.68%)	7/84 (8.33%)	6/82 (7.32%)
Injury, poisoning and procedural complications
Infusion related reaction ^† 1	3/83 (3.61%)	3/88 (3.41%)	10/84 (11.90%)	4/82 (4.88%)
Dermatitis radiation ^† 1	14/83 (16.87%)	18/88 (20.45%)	12/84 (14.29%)	13/82 (15.85%)
Investigations
Alanine aminotransferase increased ^† 1	2/83 (2.41%)	5/88 (5.68%)	10/84 (11.90%)	8/82 (9.76%)
Aspartate aminotransferase increased ^† 1	3/83 (3.61%)	3/88 (3.41%)	5/84 (5.95%)	8/82 (9.76%)
Lymphocyte count decreased ^† 1	35/83 (42.17%)	37/88 (42.05%)	36/84 (42.86%)	25/82 (30.49%)
Neutrophil count decreased ^† 1	36/83 (43.37%)	50/88 (56.82%)	40/84 (47.62%)	34/82 (41.46%)
Platelet count decreased ^† 1	10/83 (12.05%)	15/88 (17.05%)	21/84 (25.00%)	15/82 (18.29%)
Weight loss ^† 1	3/83 (3.61%)	11/88 (12.50%)	6/84 (7.14%)	5/82 (6.10%)
White blood cell decreased ^† 1	11/83 (13.25%)	28/88 (31.82%)	22/84 (26.19%)	23/82 (28.05%)
Metabolism and nutrition disorders
Anorexia ^† 1	12/83 (14.46%)	24/88 (27.27%)	15/84 (17.86%)	4/82 (4.88%)
Dehydration ^† 1	9/83 (10.84%)	21/88 (23.86%)	12/84 (14.29%)	5/82 (6.10%)
Hyperglycemia ^† 1	9/83 (10.84%)	8/88 (9.09%)	5/84 (5.95%)	2/82 (2.44%)
Hypoalbuminemia ^† 1	4/83 (4.82%)	8/88 (9.09%)	6/84 (7.14%)	5/82 (6.10%)
Hypocalcemia ^† 1	1/83 (1.20%)	5/88 (5.68%)	4/84 (4.76%)	3/82 (3.66%)
Hypokalemia ^† 1	7/83 (8.43%)	10/88 (11.36%)	7/84 (8.33%)	11/82 (13.41%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/83 (1.20%)	1/88 (1.14%)	7/84 (8.33%)	2/82 (2.44%)
Back pain ^† 1	2/83 (2.41%)	6/88 (6.82%)	7/84 (8.33%)	0/82 (0.00%)
Pain in extremity ^† 1	2/83 (2.41%)	1/88 (1.14%)	3/84 (3.57%)	5/82 (6.10%)
Nervous system disorders
Dysgeusia ^† 1	3/83 (3.61%)	7/88 (7.95%)	3/84 (3.57%)	2/82 (2.44%)
Paresthesia ^† 1	3/83 (3.61%)	8/88 (9.09%)	6/84 (7.14%)	1/82 (1.22%)
Peripheral motor neuropathy ^† 1	2/83 (2.41%)	5/88 (5.68%)	2/84 (2.38%)	1/82 (1.22%)
Peripheral sensory neuropathy ^† 1	18/83 (21.69%)	21/88 (23.86%)	25/84 (29.76%)	26/82 (31.71%)
Psychiatric disorders
Anxiety ^† 1	3/83 (3.61%)	8/88 (9.09%)	6/84 (7.14%)	4/82 (4.88%)
Depression ^† 1	2/83 (2.41%)	5/88 (5.68%)	1/84 (1.19%)	4/82 (4.88%)
Insomnia ^† 1	5/83 (6.02%)	3/88 (3.41%)	5/84 (5.95%)	3/82 (3.66%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^† 1	2/83 (2.41%)	2/88 (2.27%)	8/84 (9.52%)	3/82 (3.66%)
Skin and subcutaneous tissue disorders
Rash maculo-papular ^† 1	2/83 (2.41%)	3/88 (3.41%)	5/84 (5.95%)	3/82 (3.66%)
Palmar-plantar erythrodysesthesia syndrome ^† 1	5/83 (6.02%)	4/88 (4.55%)	4/84 (4.76%)	4/82 (4.88%)
Vascular disorders
Hypertension ^† 1	24/83 (28.92%)	16/88 (18.18%)	19/84 (22.62%)	24/82 (29.27%)
Hypotension ^† 1	7/83 (8.43%)	5/88 (5.68%)	1/84 (1.19%)	3/82 (3.66%)
Thromboembolic event ^† 1	10/83 (12.05%)	4/88 (4.55%)	7/84 (8.33%)	6/82 (7.32%)
1 Term from vocabulary, CTCAE v5.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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

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Name/Title:	Director, Department of Regulatory Affairs
Organization:	NRG Oncology
Phone:	412-339-5261
EMail:	langerj@nrgoncology.org

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

Rahma OE, Yothers G, Hong TS, Russell MM, You YN, Parker W, Jacobs SA, Colangelo LH, Lucas PC, Gollub MJ, Hall WA, Kachnic LA, Vijayvergia N, O'Rourke MA, Faller BA, Valicenti RK, Schefter TE, George S, Kainthla R, Stella PJ, Sigurdson E, Wolmark N, George TJ. Use of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: Initial Results From the Pembrolizumab Arm of a Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Aug 1;7(8):1225-1230. doi: 10.1001/jamaoncol.2021.1683. Erratum In: JAMA Oncol. 2022 Jul 1;8(7):1073.

Layout table for additonal information

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT02921256
Other Study ID Numbers:	NCI-2016-00222 NCI-2016-00222 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) NRG-GI002 s17-00197 NRG-GI002 ( Other Identifier: NRG Oncology ) NRG-GI002 ( Other Identifier: CTEP ) U10CA180868 ( U.S. NIH Grant/Contract )
First Submitted:	September 30, 2016
First Posted:	October 3, 2016
Results First Submitted:	March 8, 2023
Results First Posted:	June 9, 2023
Last Update Posted:	April 24, 2024

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