18 and older, any sex, with Rectal Adenocarcinoma or Stage II Rectal Cancer AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Neoadjuvant Rectal Cancer (NAR) ScorePrimary· 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.
Group
Value
95% CI
Arm Ia (mFOLFOX6, RT, Capecitabine)
12.6
9.8 – 15.3
Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)
13.7
10.2 – 17.2
Arm Ib (mFOLFOX6, RT, Capecitabine)
14.1
10.7 – 17.4
Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
11.5
8.5 – 14.5
Overall SurvivalSecondary· 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.
Group
Value
95% CI
Arm Ia (mFOLFOX6, RT, Capecitabine)
0.922
0.834 – 0.964
Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)
0.849
0.754 – 0.910
Arm Ib (mFOLFOX6, RT, Capecitabine)
0.867
0.772 – 0.924
Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
0.950
0.870 – 0.981
Disease Free SurvivalSecondary· 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.
Group
Value
95% CI
Arm Ia (mFOLFOX6, RT, Capecitabine)
0.675
0.559 – 0.766
Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)
0.600
0.490 – 0.694
Arm Ib (mFOLFOX6, RT, Capecitabine)
0.638
0.528 – 0.729
Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
0.636
0.522 – 0.730
Rate of Pathologic Complete Response (Nodes and Tumor) ypT0 and ypN0Secondary· 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.
Group
Value
95% CI
Arm Ia (mFOLFOX6, RT, Capecitabine)
21.6
12.9 – 32.7
Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)
33.8
23.0 – 46.0
Arm Ib (mFOLFOX6, RT, Capecitabine)
29.4
19.0 – 41.7
Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
31.9
21.2 – 44.2
Rate of Sphincter PreservationSecondary· 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.
Group
Value
95% CI
Arm Ia (mFOLFOX6, RT, Capecitabine)
52.5
41.0 – 63.8
Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)
59.3
47.8 – 70.1
Arm Ib (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
71.0
58.8 – 81.3
Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
59.4
46.9 – 71.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Deaths were assessed for up to 3 years. Adverse Events were assessed from study entry to surgery, about 7 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm Ia (mFOLFOX6, RT, Capecitabine)
Serious: 16/83 (19%)
Deaths: 7/87
Arm II (mFOLFOX6, RT, Capecitabine, Veliparib)
Serious: 25/88 (28%)
Deaths: 14/90
Arm Ib (mFOLFOX6, RT, Capecitabine)
Serious: 21/84 (25%)
Deaths: 13/93
Arm III (mFOLFOX6, RT, Capecitabine, Pembrolizumab)
This randomized phase II trial studies how well veliparib or pembrolizumab work with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving veliparib or pembrolizumab with combination chemotherapy and radiation therapy may kill more tumor cells, make the tumor smaller, and reduce the amount of normal tissue that needs to be removed.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer
· Phase 2
· not yet recruiting
NCT07494448 — Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer
· Phase 1, PHASE2
· not yet recruiting
NCT07521605 — Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer
· Phase 2
· not yet recruiting
NCT06622057 — D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
· Phase 3
· not yet recruiting
NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test
· Phase 3
· not yet recruiting
Other recruiting trials for Rectal Adenocarcinoma
Currently open trials in the same condition.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 4 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02921256.