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Checkpoint Inhibitor
Immunotherapy + Chemotherapy for Rectal Cancer (PANTHER Trial)
Phase 2
Recruiting
Led By Encouse Golden, M.D., Ph.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Rectal cancer amenable to total mesorectal excision
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
PANTHER Trial Summary
This trial is testing a new combination of drugs to treat pelvic cancer. The patients will first receive a short course of radiation, followed by chemotherapy.
Who is the study for?
Adults with rectal cancer that hasn't spread or been treated yet can join this trial. They need to be in good health, not have had prior pelvic radiation or chemotherapy for rectal cancer, and agree to use contraception. Pregnant women, those with recent severe illnesses or allergies to similar drugs, and patients on certain medications are excluded.Check my eligibility
What is being tested?
The study tests a combination of new drugs (Zimberelimab and Etrumadenant) with standard chemo (FOLFOX regimen) after initial short-course radiation therapy. The goal is to see if this combo is safe and works better for treating rectal cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells, infusion-related reactions from the drug entering the body, blood disorders like anemia or clotting problems, fatigue, nausea, diarrhea, and increased risk of infections.
PANTHER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My rectal cancer can be surgically removed with a specific technique.
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I have not had radiation therapy to my pelvic area.
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I have not had chemotherapy or surgery for rectal cancer.
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My condition is located more than 5cm from the anal opening.
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My cancer is at a specific stage according to tumor size and lymph node involvement.
Select...
My condition is confirmed rectal adenocarcinoma.
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My cancer has not spread to distant parts of my body.
Select...
I am not on antibiotics for an infection.
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I am fully active or can carry out light work.
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I am not pregnant and agree to use birth control during the study.
PANTHER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of treated patients who achieve complete pathologic response
Secondary outcome measures
Therapeutic procedure
Overall survival
Progression free survival
Side effects data
From 2013 Phase 3 trial • 397 Patients • NCT0000405478%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Platelet count decreased
1%
Blood albumin decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy
PANTHER Trial Design
1Treatment groups
Experimental Treatment
Group I: Radiation therapy and etrumadenant (AB928)Experimental Treatment4 Interventions
Enrolled patients will receive Radiation therapy of 25 Gy in 5 fractions along with etrumadenant 150mg oral drug taken once daily. this will then be followed by 9 cycles of FOLFOX in combination of etrumadenant and zimberelimab investigational drugs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2850
FOLFOX regimen
2009
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
Arcus Biosciences, Inc.Industry Sponsor
41 Previous Clinical Trials
6,023 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,266 Total Patients Enrolled
Encouse Golden, M.D., Ph.D.Principal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had a blood clot in an artery in the last 6 months.I am not pregnant and agree to use birth control during the study.I agree to use effective birth control methods.I haven't taken any specific heart medication that affects drug transport in my body within the last 4 weeks.My rectal cancer can be surgically removed with a specific technique.I have 4 or more large lymph nodes in my pelvis.I have been treated with medication targeting the adenosine pathway before.My cancer affects the edge of tissue removed during surgery.I will use effective birth control or abstain from sex during and up to 90 days after treatment.I have not had radiation therapy to my pelvic area.I can take pills without issues like swallowing difficulty or constant nausea.My cancer is suspected to be very advanced.I have had radiation therapy to my pelvic area before.I have had a clot or heart issue over 6 months ago and am on a stable blood thinner.I haven't taken specific oral medications like prazosin or rosuvastatin recently.My rectal cancer cannot be surgically removed due to its attachment to nearby structures.I have not had chemotherapy or surgery for rectal cancer.I agree to use effective birth control methods.My condition is located more than 5cm from the anal opening.My cancer is at a specific stage according to tumor size and lymph node involvement.I have not had any cancer in the past 5 years, except for certain skin cancers or cervical cancer that was caught early and treated.My condition is confirmed rectal adenocarcinoma.My cancer has not spread to distant parts of my body.I am not on antibiotics for an infection.I am a woman of childbearing age and have a negative pregnancy test.I am fully active or can carry out light work.I am not on any other cancer treatments or experimental drugs.I am not pregnant and agree to use birth control during the study.My rectal cancer has come back.I haven't taken strong medication or substances that affect liver enzymes recently.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation therapy and etrumadenant (AB928)
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.
Is admission to this research program still accessible for participants?
"Concurrently, this medical trial is in search of potential participants. According to the data hosted on clinicaltrials.gov, it was originally published on March 31st 2022 and underwent a recent update on April 10th 2022."
Answered by AI
What potential risks do patients face when undergoing Radiation therapy?
"Although some safety data is available, the lack of any efficacy information resulted in Radiation therapy receiving a score of 2."
Answered by AI
How extensive is the participant enrollment of this research project?
"Affirmative. The clinicaltrials.gov website states that this investigation, which was originally advertised on March 31st 2022, is actively searching for participants. Around 43 individuals must be enrolled from 3 different medical sites."
Answered by AI
Am I qualified to be a participant in this research?
"This clinical trial seeks 43 individuals with rectal carcinoma, aged 18 to 90. Prerequisites are: Eastern Cooperative Oncology Group performance rating of 0-1; no earlier pelvic radiation therapy; not having had any chemotherapy or surgery for rectal cancer in the past; at least 5 centimeters from the anal verge; appearance without distant metastases and unencumbered by bacterial infections necessitating systemic antibiotic administration."
Answered by AI
Is the enrollment of participants over 55 years old accepted in this trial?
"This study is available to those aged 18-90. If you are younger than the age of consent, there are 11 clinical trials that may suit your needs and if you're over 65 years old then 336 other medical experiments could be right for you."
Answered by AI
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