Rectal CancerPhase 1/2NCT03516708
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
A Phase 1/2 study testing Epacadostat, Short-course radiation therapy and CAPOX chemotherapy in people with Rectal Cancer, run by Washington University School of Medicine at 4 sites in United States.
Trial summary
The purpose of this research study is to evaluate epacadostat when given with routine radiation therapy and chemotherapy (capecitabine and oxaliplatin) to treat rectal cancer before routine surgery is performed to remove the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Epacadostat, Short-course radiation therapy and CAPOX chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Jan 2020to 12 Aug 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed pathologically-confirmed locally advanced rectal cancer (defined by 8th edition AJCC stage 2 or 3, or stage 1 not eligible for sphincter-sparing surgery) with plans to proceed with total neoadjuvant short course radiation as part of their neoadjuvant therapy as confirmed by treating physician
- At least 18 years of age.
- ECOG performance status 0, 1, or 2
- Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1.5 K/cumm
- Platelets ≥ 100 K/cumm
Show all 13Show fewer
- Hemoglobin > 9 g/dL
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
- Serum creatinine < 1.5 x IULN OR measured or calculated creatinine clearance ≥ 50 mL/min/1.73 m2
- Applicable to subjects enrolled at Washington University and Dana Farber Cancer Institute only: Willing to undergo study-related biopsies subject to accessibility of tumor, appropriateness of biopsy (not contraindicated), and continued subject consent. If biopsy is not safe and feasible per treating physician, then patient may still enroll with permission of sponsor-investigator.
- Women of childbearing potential and men must agree to contraceptive methods as described in protocol prior to study entry, for the duration of study participation, and for 120 days after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Received prior anti-cancer therapy for rectal cancer.
- Prior treatment with agents targeting IDO pathway (including indoximod)
- Previous radiotherapy in the pelvic region or previous rectal surgery (e.g. TEM) or any investigational treatment for rectal cancer within the past month.
- Known or suspected presence of another malignancy that could be mistaken for the malignancy under study during disease assessments.
- Currently receiving any other investigational agents.
- Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumor downsizing is seen.
Show all 20Show fewer
- Presence of metastatic disease or recurrent rectal tumor.
- Diagnosis of Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease, or active ulcerative colitis.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to epacadostat, pembrolizumab, 5-FU, oxaliplatin, or other agents used in the study.
- Has an active infection requiring systemic therapy.
- Warfarin (Coumadin): patients currently on warfarin are excluded. Patients who go off warfarin and have INR within normal limits have no washout period.
- Any history of serotonin syndrome (SS) after receiving serotonergic drugs. This syndrome has been most closely associated with the use of MAOIs, meriperidine, linezolid, or methylene blue; all of these agents are prohibited during the study
- Uncontrolled intercurrent illness including, but not limited to active tuberculosis infection, pneumonitis requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Has an active or inactive autoimmune disease or syndrome (i.e. rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 2 years or is receiving systemic therapy for an autoimmune or inflammatory disease (i.e. with use of modifying agents, corticosteroids, or immunosuppressive drugs). Exceptions include subjects with vitiligo or resolved childhood asthma/atopy, hypothyroidism stable on hormone replacement, controlled asthma, Type I diabetes, Graves' disease, or Hashimoto's disease.
- An abnormal screening ECG that, in the investigator's opinion, is clinically meaningful.
- Presence of a gastrointestinal condition that may affect drug absorption.
- Receipt of live attenuated vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of planned start of study therapy.
- Known active hepatitis B (e.g. HBsAg reactive or HBV DNA detected) or hepatitis C (e.g. HCV RNA [qualitative] is detected) infection. Testing at screening is required (Serology testing with HBsAg, HBsAb, and HCV Ab are required; HBV DNA or HCV RNA are only required in the setting of serology tests compatible with possible active infection.).
- Known microsatellite instability- high (MSI-H) or mismatch repair deficient rectal cancer.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 2 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Haeseong Park, M.D., MPH, 857-215-1230, haeseong_park@dfci.harvard.edu
Haeseong Park, M.D., MPH
- Withdrawn
Henry Ford Cancer Institute
Detroit, Michigan, 48202
- Withdrawn
University of California Irvine - Chao Family Comprehensive Cancer Center
Orange, California, 92868
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Moh'd Khushman, M.D., 314-273-3564, mkhushman@wustl.edu
Moh'd Khushman, M.D.
About this study
Official title: Phase I/II Study of Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
The purpose of this research study is to evaluate epacadostat when given with routine radiation therapy and chemotherapy (capecitabine and oxaliplatin) to treat rectal cancer before routine surgery is performed to remove the tumor.
- Conditions
- Rectal Cancer
- Being tested
- Epacadostat, Short-course radiation therapy, CAPOX chemotherapy, FOLFOX chemotherapy
- Keywords
- Immunotherapy, Kynurenine, Colon, Indoleamine 2,3 dioxygenase, IDO1
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpacadostatDrug
Also called INCB024360
Drug provided.
Short-course radiation therapyRadiation
Also called SCRT
Short-course pelvic radiation therapy, 5 Gy x 5 fractions over 1 week
CAPOX chemotherapyDrug
Standard of care
FOLFOX chemotherapyDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort (Phase I): Epacadostat + SCRT + Chemotherapy + Surgery | Experimental | * Epacadostat at the designated dose level starting on the 1st day of radiation therapy and continuing throughout chemotherapy until the day of surgery.
* Standard of care preoperative therapy will consist of a total of approximately 20-24 weeks of short-course pelvic radiation and chemotherapy:
* Cycle 0 Days 1-7(Week 1): Short-course pelvic radiation therapy (SCRT), 5 fractions over 1 week
* Cycle 0 Days 8-21 or 8-28 (Weeks 2-4): Treatment break for 2 to 3 weeks; for patients enrolled at Washington University and Dana Farber only, tumor biopsy will be obtained between the end of RT and prior to chemotherapy (target Days 14-28)
* Cycles 1-6: (6) 21-day cycles of CAPOX for a total of 18 weeks. CAPOX is typically capecitabine at 1000 mg/m^2 PO BID (days 1-14 of each cycle) and oxaliplatin 130 mg/m^2 IV Q3W.
* Surgery will follow approximately 4 to 6 weeks after completion of CAPOX Receives: Drug: Epacadostat; Radiation: Short-course radiation therapy; Drug: CAPOX chemotherapy |
| Phase II Treatment Cohort: Epacadostat + SCRT + Chemotherapy + Surgery | Experimental | * Epacadostat 400 mg BID 1st day of radiation therapy and continuing for ~28 days, until biopsy (with the exception of patients enrolling to dose expansion and starting on epacadostat with neoadjuvant chemotherapy prior to approval of post-sIRB A2)
* Preoperative therapy approximately 20-24 weeks of chemoradiation:
* Week 1: SCRT, typically 5 Gy x 5 fractions over 1 week, with epacadostat 400 mg BID starting on D1 of SCRT
* Weeks 2-4: Epacadostat monotherapy 400 mg BID \& continued for a minimum of 21 days, until the day prior to chemotherapy
* For patients enrolled at Washington University and Dana Farber Cancer Institute ONLY, tumor biopsy between the end of RT and prior to initiation of chemotherapy. Tumor biopsy target of between Days 15-28
* Weeks 3-6: 4-5 weeks after completion of SCRT \& after completion of approximately 21-35 days of epacadostat, SOC neoadjuvant chemotherapy of CAPOX or FOLFOX will be initiated
* Surgery will occur approximately 4-6 weeks after chemotherapy Receives: Drug: Epacadostat; Radiation: Short-course radiation therapy; Drug: CAPOX chemotherapy; Drug: FOLFOX chemotherapy |
| Phase II Biomarker Cohort: SCRT + Chemotherapy + Surgery | Active comparator | Washington University and Dana Farber only: Patients enrolled to this cohort will not receive epacadostat. Patients will undergo standard of care preoperative therapy consisting of approximately 20 to 24 weeks of chemoradiation. All treatment will be administered in this cohort as per institutional standard. The expected schedule for these patients will consist of 1 week of short-course pelvic radiation therapy, followed by a treatment break, followed by neoadjuvant chemotherapy. Approximately 4 to 6 weeks after completion of neoadjuvant chemotherapy, patients may undergo surgery. Tumor biopsy may occur at screening and after completion of RT, prior to starting neoadjuvant chemotherapy. Receives: Radiation: Short-course radiation therapy; Drug: CAPOX chemotherapy; Drug: FOLFOX chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I only: Recommended phase II dose (RP2D) of epacadostat with standard of care radiation and chemotherapy in preoperative treatment of locally advanced rectal cancer
The recommended phase 2 dose (RP2D) is defined as the dose level immediately below the maximally administered dose at which 0 or 1 of a cohort of 3 to 6 patients experienced a dose-limiting toxicity (DLT) during first 2 cycles.
Measured: Completion of the first 2 cycles of treatment for all patients (estimated to be 86 months)
Phase II Treatment Cohort only: Neoadjuvant Rectal (NAR) Score
Neoadjuvant Rectal Score (NAR Score) is calculated by following formula: NAR = ([5pN
- 3(cT - pT) + 12]2)/9.61 (with higher scores representing poorer prognosis), where cT=clinical tumor stage, pT=pathologic tumor stage, and pN=pathologic nodal stage.
Measured: At the time of surgery (approximately week 28)
Secondary outcomes (5)
Phase I and Phase II Treatment Cohort only: Safety and toxicity profile of the combination as measured by adverse events experienced
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Measured: Through 4 weeks after completion of treatment (approximately 28 weeks)
Phase I only: Neoadjuvant Rectal (NAR) Score
Neoadjuvant Rectal Score (NAR Score) is calculated by following formula: NAR = ([5pN
- 3(cT - pT) + 12]2)/9.61 (with higher scores representing poorer prognosis), where cT=clinical tumor stage, pT=pathologic tumor stage, and pN=pathologic nodal stage.
Measured: At the time of surgery (approximately week 28)
Phase I and Phase II Treatment Cohort only: Pathological complete response rate (pCR)
Pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical specimen.
Measured: At the time of surgery (approximately week 25)
Phase I and Phase II Treatment Cohort only: Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. For those who are alive and do not experience progression, they are censored at the time of loss to follow-up.
Measured: Through completion of follow-up (estimated to be 3 years and 32 weeks)
Phase I and Phase II Treatment Cohort only: Complete clinical response rate (cCR)
Clinical complete response (cCR) is defined as no clinical evidence of tumor as assessed by radiographic, endoscopic, and physical examinations after completion of planned protocol therapy.
Measured: At the time of preoperative assessment (approximately week 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start6 Jan 2020
- Primary completion15 Jul 2027 (estimated)
- Study completion12 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Moh'd Khusman, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516708
- Sponsor's protocol ID
- 202305133 (201902040)
- Other IDs
- 1R01CA278197
- Status last verified
- Feb 2026
- First submitted
- 24 Apr 2018
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT03516708
- Acronym / sponsor ID
- 202305133 (201902040)
- Conditions
- Rectal Cancer
- Keywords
- Immunotherapy, Kynurenine, Colon, Indoleamine 2,3 dioxygenase, IDO1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Incyte Corporation, National Cancer Institute (NCI)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 12 Aug 2030 (estimated)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate epacadostat when given with routine radiation therapy and chemotherapy (capecitabine and oxaliplatin) to treat rectal cancer before routine surgery is performed to remove the tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort (Phase I): Epacadostat + SCRT + Chemotherapy + Surgery | Experimental | Drug: Epacadostat, Radiation: Short-course radiation therapy, Drug: CAPOX chemotherapy* Epacadostat at the designated dose level starting on the 1st day of radiation therapy and continuing throughout chemotherapy until the day of surgery. * Standard of care preoperative therapy will consist of a total of approximately 20-24 weeks of short-course pelvic radiation and chemotherapy: * Cycle 0 Days 1-7(Week 1): Short-course pelvic radiation therapy (SCRT), 5 fractions over 1 week * Cycle 0 Days 8-21 or 8-28 (Weeks 2-4): Treatment break for 2 to 3 weeks; for patients enrolled at Washington University and Dana Farber only, tumor biopsy will be obtained between the end of RT and prior to chemotherapy (target Days 14-28) * Cycles 1-6: (6) 21-day cycles of CAPOX for a total of 18 weeks. CAPOX is typically capecitabine at 1000 mg/m^2 PO BID (days 1-14 of each cycle) and oxaliplatin 130 mg/m^2 IV Q3W. * Surgery will follow approximately 4 to 6 weeks after completion of CAPOX |
| Phase II Treatment Cohort: Epacadostat + SCRT + Chemotherapy + Surgery | Experimental | Drug: Epacadostat, Radiation: Short-course radiation therapy, Drug: CAPOX chemotherapy, Drug: FOLFOX chemotherapy* Epacadostat 400 mg BID 1st day of radiation therapy and continuing for ~28 days, until biopsy (with the exception of patients enrolling to dose expansion and starting on epacadostat with neoadjuvant chemotherapy prior to approval of post-sIRB A2) * Preoperative therapy approximately 20-24 weeks of chemoradiation: * Week 1: SCRT, typically 5 Gy x 5 fractions over 1 week, with epacadostat 400 mg BID starting on D1 of SCRT * Weeks 2-4: Epacadostat monotherapy 400 mg BID \& continued for a minimum of 21 days, until the day prior to chemotherapy * For patients enrolled at Washington University and Dana Farber Cancer Institute ONLY, tumor biopsy between the end of RT and prior to initiation of chemotherapy. Tumor biopsy target of between Days 15-28 * Weeks 3-6: 4-5 weeks after completion of SCRT \& after completion of approximately 21-35 days of epacadostat, SOC neoadjuvant chemotherapy of CAPOX or FOLFOX will be initiated * Surgery will occur approximately 4-6 weeks after chemotherapy |
| Phase II Biomarker Cohort: SCRT + Chemotherapy + Surgery | Active comparator | Radiation: Short-course radiation therapy, Drug: CAPOX chemotherapy, Drug: FOLFOX chemotherapyWashington University and Dana Farber only: Patients enrolled to this cohort will not receive epacadostat. Patients will undergo standard of care preoperative therapy consisting of approximately 20 to 24 weeks of chemoradiation. All treatment will be administered in this cohort as per institutional standard. The expected schedule for these patients will consist of 1 week of short-course pelvic radiation therapy, followed by a treatment break, followed by neoadjuvant chemotherapy. Approximately 4 to 6 weeks after completion of neoadjuvant chemotherapy, patients may undergo surgery. Tumor biopsy may occur at screening and after completion of RT, prior to starting neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Newly diagnosed pathologically-confirmed locally advanced rectal cancer (defined by 8th edition AJCC stage 2 or 3, or stage 1 not eligible for sphincter-sparing surgery) with plans to proceed with total neoadjuvant short course radiation as part of their neoadjuvant therapy as confirmed by treating physician
- At least 18 years of age.
- ECOG performance status 0, 1, or 2
- Adequate bone marrow and organ function as defined below:
- Applicable to subjects enrolled at Washington University and Dana Farber Cancer Institute only: Willing to undergo study-related biopsies subject to accessibility of tumor, appropriateness of biopsy (not contraindicated), and continued subject consent. If biopsy is not safe and feasible per treating physician, then patient may still enroll with permission of sponsor-investigator.
Key exclusion criteria (20 listed)
- Received prior anti-cancer therapy for rectal cancer.
- Prior treatment with agents targeting IDO pathway (including indoximod)
- Previous radiotherapy in the pelvic region or previous rectal surgery (e.g. TEM) or any investigational treatment for rectal cancer within the past month.
- Known or suspected presence of another malignancy that could be mistaken for the malignancy under study during disease assessments.
- Currently receiving any other investigational agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpacadostatAlso: INCB024360Drug provided. | Drug | Dose Escalation Cohort (Phase I): Epacadostat + SCRT + Chemotherapy + Surgery, Phase II Treatment Cohort: Epacadostat + SCRT + Chemotherapy + Surgery |
| Short-course radiation therapyAlso: SCRTShort-course pelvic radiation therapy, 5 Gy x 5 fractions over 1 week | Radiation | Dose Escalation Cohort (Phase I): Epacadostat + SCRT + Chemotherapy + Surgery, Phase II Biomarker Cohort: SCRT + Chemotherapy + Surgery, Phase II Treatment Cohort: Epacadostat + SCRT + Chemotherapy + Surgery |
| CAPOX chemotherapyStandard of care | Drug | Dose Escalation Cohort (Phase I): Epacadostat + SCRT + Chemotherapy + Surgery, Phase II Biomarker Cohort: SCRT + Chemotherapy + Surgery, Phase II Treatment Cohort: Epacadostat + SCRT + Chemotherapy + Surgery |
| FOLFOX chemotherapyStandard of care | Drug | Phase II Biomarker Cohort: SCRT + Chemotherapy + Surgery, Phase II Treatment Cohort: Epacadostat + SCRT + Chemotherapy + Surgery |
Primary outcome
Phase I only: Recommended phase II dose (RP2D) of epacadostat with standard of care radiation and chemotherapy in preoperative treatment of locally advanced rectal cancer
Time frame: Completion of the first 2 cycles of treatment for all patients (estimated to be 86 months)
The recommended phase 2 dose (RP2D) is defined as the dose level immediately below the maximally administered dose at which 0 or 1 of a cohort of 3 to 6 patients experienced a dose-limiting toxicity (DLT) during first 2 cycles.
Phase II Treatment Cohort only: Neoadjuvant Rectal (NAR) Score
Time frame: At the time of surgery (approximately week 28)
Neoadjuvant Rectal Score (NAR Score) is calculated by following formula: NAR = ([5pN - 3(cT - pT) + 12]2)/9.61 (with higher scores representing poorer prognosis), where cT=clinical tumor stage, pT=pathologic tumor stage, and pN=pathologic nodal stage.
5 secondary outcomes
Phase I and Phase II Treatment Cohort only: Safety and toxicity profile of the combination as measured by adverse events experienced
Time frame: Through 4 weeks after completion of treatment (approximately 28 weeks)
Phase I only: Neoadjuvant Rectal (NAR) Score
Time frame: At the time of surgery (approximately week 28)
Phase I and Phase II Treatment Cohort only: Pathological complete response rate (pCR)
Time frame: At the time of surgery (approximately week 25)
Phase I and Phase II Treatment Cohort only: Progression-free survival (PFS)
Time frame: Through completion of follow-up (estimated to be 3 years and 32 weeks)
Phase I and Phase II Treatment Cohort only: Complete clinical response rate (cCR)
Time frame: At the time of preoperative assessment (approximately week 28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moh'd Khusman, M.D. principal investigator
Washington University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epacadostat, Short-course radiation therapy and CAPOX chemotherapy in people with Rectal Cancer, run by Washington University School of Medicine at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moh'd Khushman, M.D. (314-273-3564, mkhushman@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I only: Recommended phase II dose (RP2D) of epacadostat with standard of care radiation and chemotherapy in preoperative treatment of locally advanced rectal cancer (time frame: Completion of the first 2 cycles of treatment for all patients (estimated to be 86 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.