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IDO1 Inhibitor
Epacadostat + Chemoradiation for Rectal Cancer
Phase 1 & 2
Recruiting
Led By Haeseong Park, M.D., M.P.H.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed locally advanced rectal cancer with pathology confirmation with plans to proceed with neoadjuvant short course radiation and chemotherapy as confirmed by treating physician
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 3 years and 32 weeks)
Awards & highlights
Study Summary
This trial is testing a new cancer drug in combination with radiation and chemo for rectal cancer patients before surgery.
Who is the study for?
This trial is for adults with newly diagnosed locally advanced rectal cancer who are planning to receive neoadjuvant radiation and chemotherapy. Participants must be in good physical condition (ECOG ≤ 1), have normal organ and bone marrow function, agree to use contraception, and not have had previous cancer treatments or certain other medical conditions.Check my eligibility
What is being tested?
The study tests epacadostat combined with CAPOX chemotherapy and short-course radiation before surgery for rectal cancer. It aims to see if this combination improves outcomes compared to the standard preoperative treatment.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to epacadostat, digestive issues from chemotherapy, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver enzyme alterations, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed with advanced rectal cancer and will undergo radiation and chemotherapy.
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I am 18 years old or older.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My kidney function is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 3 years and 32 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 3 years and 32 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Phase II Treatment Cohort only: Neoadjuvant Rectal (NAR) Score
Secondary outcome measures
Phase I and Phase II Treatment Cohort only: Complete clinical response rate (cCR)
Phase I and Phase II Treatment Cohort only: Pathological complete response rate (pCR)
Phase I and Phase II Treatment Cohort only: Progression-free survival (PFS)
+2 moreSide effects data
From 2020 Phase 3 trial • 93 Patients • NCT0336186533%
Anaemia
23%
Diarrhoea
23%
Rash
23%
Pruritus
21%
Asthenia
19%
Malignant neoplasm progression
16%
Back pain
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Dyspnoea
12%
Urinary tract infection
12%
Blood creatinine increased
12%
Decreased appetite
12%
Hypoalbuminaemia
12%
Pyrexia
9%
Lipase increased
9%
Amylase increased
9%
Aspartate aminotransferase increased
9%
Cough
9%
Hypocalcaemia
9%
Pneumonitis
9%
Haematuria
9%
Vomiting
9%
Alanine aminotransferase increased
7%
Arthralgia
7%
Creatinine renal clearance decreased
7%
Hyperuricaemia
7%
Insomnia
7%
Oedema peripheral
7%
Dysuria
7%
Hyperkalaemia
7%
Hypothyroidism
7%
Pneumonia
7%
Weight decreased
5%
Urosepsis
5%
Abdominal pain
5%
Blood alkaline phosphatase increased
5%
Device occlusion
5%
Pain in extremity
2%
Hypophysitis
2%
Renal impairment
2%
Urticaria
2%
Musculoskeletal pain
2%
Death
2%
Encephalitis
2%
Hepatitis
2%
Left ventricular dysfunction
2%
Lymph gland infection
2%
Nephropathy toxic
2%
Pneumocystis jirovecii pneumonia
2%
Renal failure
2%
Small intestinal obstruction
2%
Somnolence
2%
Supraventricular tachycardia
2%
Urinary tract stoma complication
2%
Herpes zoster
2%
Flank pain
2%
Septic shock
2%
Gastroenteritis
2%
Hypercalcaemia
2%
Lung neoplasm malignant
2%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab 200 mg + Epacadostat 100 mg BID
Pembrolizumab 200 mg + Placebo BID
Total
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Phase II Treatment Cohort: Epacadostat + SCRT + Chemotherapy + SurgeryExperimental Treatment3 Interventions
Epacadostat 400 mg BID starting the day of radiation therapy, throughout chemotherapy, and until the day of surgery
Epacadostat is taken by mouth twice per day every day of each 21 day cycle
Standard of care preoperative therapy will consist of a total of approximately 20-24 weeks' chemoradiation followed by surgery. Breakdown of the preoperative therapy are as follows:
Cycle 1 Days 1-7 (Week 1): Short-course pelvic radiation therapy, typically 5 fractions over 1 week
Cycle 0 Days 8-21 or 28 (Weeks2-4): Treatment break for 2-3 weeks; tumor biopsy will be obtained between the end of RT and prior to chemotherapy (for patients enrolled at Washington University and Dana Farber Cancer Institute only)
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 3-week cycle) and oxaliplatin 130 mg/m^2 IV Q3W.
Surgery will follow approximately 4 to 6 weeks after completion of chemotherapy
Group II: Dose Escalation Cohort (Phase I): Epacadostat + SCRT + Chemotherapy + SurgeryExperimental Treatment3 Interventions
Epacadostat at the designated dose level starting the day of radiation therapy, throughout chemotherapy, and until the day of surgery
Epacadostat is taken by mouth twice per day every day of each 21 day cycle
Standard of care preoperative therapy will consist of a total of approximately 20-24 weeks' preoperative therapy followed by surgery. Breakdown of the 20-24 weeks of preoperative therapy are as follows:
Week 1: Short-course pelvic radiation therapy, 5 fractions over 1 week
Weeks 2-4: Treatment break for 2 to 4 weeks; for patients enrolled at Washington University only, tumor biopsy will be obtained on or after the last radiation day (D5-8) and before the start of chemotherapy (D21-28)
6 cycles of CAPOX for a total of 18 weeks
surgery will follow approximately 4 to 6 weeks after completion of chemotherapy
CAPOX is typically capecitabine at 1000 mg/m2 PO BID and oxaliplatin 130 mg/m2 IV Q3W. The second cycle of epacadostat will begin when CAPOX starts
Group III: Phase II Biomarker Cohort: SCRT + Chemotherapy + SurgeryActive Control2 Interventions
-Patients enrolled to the biomarker cohort will not receive epacadostat but will only receive standard of care preoperative therapy consisting of a total of approximately 20 to 24 weeks of chemoradiation as follows:
Cycle 0 Days 1-7 (Week 1): Short-course pelvic radiation therapy, typically 5 Gy x 5 fractions over 1 week
Cycle 0 Days 8-21 or 28 (Weeks 2-4): treatment break for 2 to 3 weeks; for patients enrolled at Washington University and Dana Farber Cancer Institute ONLY, tumor biopsy will be obtained between the end of RT and prior to initiation of chemotherapy via proctoscopy or sigmoidoscopy (if safe, feasible, and evidence of necessary) (target Days 5-28)
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 3-week cycle) and oxaliplatin 130 mg/m^2 IV Q3W.
Surgery will follow approximately 4 to 6 weeks after completion of CAPOX, although surgery may occur outside this timeframe.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epacadostat
2018
Completed Phase 3
~1080
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,771 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,926,159 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
55,150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any live vaccines in the last 30 days.I do not have lung inflammation or disease that needed treatment.I have had treatment for rectal cancer before.I have not had pelvic radiotherapy, rectal surgery, or experimental treatments for rectal cancer in the last month.My tumor has grown into the upper part of my sacrum or nerve roots, making surgery impossible.My cancer has spread or my rectal tumor has come back.My blood tests for bone marrow and organ function are normal.My kidney function is within the normal range.My blood clotting tests are within safe limits, even if I'm on blood thinners.My blood clotting time is normal or managed with medication.I agree to have biopsies for the study if my tumor can be safely biopsied.I can understand and am willing to sign the consent form.I have an active hepatitis B or C infection confirmed by tests.I have had allergic reactions to certain cancer drugs before.I am currently being treated for an infection.I have had serotonin syndrome from certain medications before.I do not have any uncontrolled illnesses like heart failure or irregular heartbeat.I have an autoimmune disease and have been treated for it in the last 2 years.I have a stomach or intestine condition that could affect how medicines work for me.I have active tuberculosis.My rectal cancer is MSI-H or has mismatch repair deficiency.I have been newly diagnosed with advanced rectal cancer and will undergo radiation and chemotherapy.I am 18 years old or older.I am fully active and can carry on all my pre-disease activities without restriction.I have been diagnosed with FAP, HNPCC, Crohn's disease, or ulcerative colitis.I have previously been treated with specific immune-targeting cancer drugs.I am not currently taking warfarin, or I stopped and my INR is normal.I have had cancer in the past 3 years, but it was a type that could be cured and has been.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Cohort (Phase I): Epacadostat + SCRT + Chemotherapy + Surgery
- Group 2: Phase II Treatment Cohort: Epacadostat + SCRT + Chemotherapy + Surgery
- Group 3: Phase II Biomarker Cohort: SCRT + Chemotherapy + Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree of risk do patients expose themselves to when taking Epacadostat?
"The limited clinical data available on Epacadostat's efficacy and safety has lead to its score of 1 in terms of security."
Answered by AI
How many individuals are engaged in this research?
"A total of 39 qualified patients are needed to carry out this clinical trial. The sponsor, Incyte Corporation, is managing the research across multiple locations including Henry Ford Cancer Institute in Detroit and Washington University School of Medicine in Saint Louis."
Answered by AI
In what other research studies has Epacadostat been utilized?
"At the time of this writing, 13 clinical trials are investigating epacadostat with 2 in Phase 3. Minneapolis is home to most of these studies but there are 369 additional locations where research is being conducted."
Answered by AI
Is enrollment for this clinical trial still open?
"The details uploaded on clinicaltrials.gov relate that this medical trial is actively recruiting patients, with the original post date being October 10th 2019 and last updated on July 6th 2022."
Answered by AI
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