← Back to Search

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
Must not have
≥4 regional lymph nodes each ≥10 mm on pelvic MRI
Prior treatment with an agent targeting the adenosine pathway
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial uses a combination of radiation therapy, medication, and chemotherapy to treat patients with advanced pelvic tumors. The goal is to shrink the tumors, kill cancer cells, and enhance the overall effectiveness of the treatment.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My rectal cancer can be surgically removed with a specific technique.
Select...
I have not had radiation therapy to my pelvic area.
Select...
I have not had chemotherapy or surgery for rectal cancer.
Select...
My condition is located more than 5cm from the anal opening.
Select...
My cancer is at a specific stage according to tumor size and lymph node involvement.
Select...
My condition is confirmed rectal adenocarcinoma.
Select...
My cancer has not spread to distant parts of my body.
Select...
I am not on antibiotics for an infection.
Select...
I am fully active or can carry out light work.
Select...
I am not pregnant and agree to use birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have 4 or more large lymph nodes in my pelvis.
Select...
I have been treated with medication targeting the adenosine pathway before.
Select...
My cancer affects the edge of tissue removed during surgery.
Select...
I can take pills without issues like swallowing difficulty or constant nausea.
Select...
My cancer is suspected to be very advanced.
Select...
I have had radiation therapy to my pelvic area before.
Select...
My rectal cancer cannot be surgically removed due to its attachment to nearby structures.
Select...
I am not on any other cancer treatments or experimental drugs.
Select...
My rectal cancer has come back.
Select...
I haven't taken strong medication or substances that affect liver enzymes recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of treated patients who achieve complete pathologic response
Secondary study objectives
Therapeutic procedure
Overall survival
Progression free survival

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054
78%
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: NOS
12%
Late RT Toxicity: Other GI: 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%
Depression NEC
2%
Nausea
2%
Hyperglycemia NOS
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Platelet count decreased
1%
Hyponatremia
1%
Hypocalcemia
1%
Blood albumin decreased
1%
Stomatitis
1%
Weight decreased
1%
Anorexia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as mFOLFOX, works by damaging the DNA of cancer cells, preventing them from dividing and growing. Targeted therapies, like bevacizumab, inhibit specific molecules involved in tumor growth and angiogenesis. Immunotherapy, including PD-1 inhibitors like AB122, enhances the immune system's ability to recognize and destroy cancer cells. Adenosine receptor antagonists like AB928 block adenosine signaling, which can suppress immune responses in the tumor microenvironment. These mechanisms are crucial for colorectal cancer patients as they offer multiple strategies to attack cancer cells, potentially improving treatment efficacy and patient outcomes.
Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma.Disparity between Inter-Patient Molecular Heterogeneity and Repertoires of Target Drugs Used for Different Types of Cancer in Clinical Oncology.Compound-therapy based on cancer-immunity cycle: promising prospects for antitumor regimens.

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Industry Sponsor
43 Previous Clinical Trials
7,149 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,702 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

AB122 (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05024097 — Phase 2
Colorectal Cancer Research Study Groups: Radiation therapy and etrumadenant (AB928)
Colorectal Cancer Clinical Trial 2023: AB122 Highlights & Side Effects. Trial Name: NCT05024097 — Phase 2
AB122 (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05024097 — Phase 2
~11 spots leftby Dec 2025