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Monoclonal Antibodies
Combination Immunotherapy for Kidney Cancer (ARCITECT Trial)
Phase 2
Recruiting
Led By Michael B Atkins, MD
Research Sponsored by Michael B. Atkins, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years old at the time of informed consent
Patient must have histological confirmation of renal carcinoma with clear cell component including advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
ARCITECT Trial Summary
This trial compares two novel cancer treatments in patients with advanced kidney cancer to see if they are more effective than current treatments. 120 patients will be enrolled.
Who is the study for?
Adults with advanced or metastatic renal cell carcinoma (kidney cancer) who haven't had certain treatments can join. They need measurable disease, proper organ function, and no recent major surgery. Women must test negative for pregnancy and agree to contraception; men too if with women of childbearing potential. HIV-positive patients can join under specific conditions.Check my eligibility
What is being tested?
The trial is testing botensilimab with balstilimab against ipilimumab with nivolumab in a randomized open-label study. Patients are assigned to one of two groups in a 2:1 ratio and treated until toxicity, progression, or up to 96 weeks.See study design
What are the potential side effects?
Potential side effects include immune-related inflammation in various organs, infusion reactions like fever or chills, fatigue, digestive issues such as diarrhea or nausea, blood disorders like anemia or clotting problems, increased risk of infections.
ARCITECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My kidney cancer is confirmed and cannot be cured with surgery or radiation.
ARCITECT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the objective response rate (ORR) of botensilimab + balstilimab in patients with treatment naïve metastatic ccRCC relative to the ORR of patients treated with ipilimumab + nivolumab.
Secondary outcome measures
Determine Duration of response (DOR) for patients who have a CR or PR
Determine the 12- & 24-month landmark progression free survival (PFS)
Determine the safety of botensilimab + balstilimab relative to ipilimumab + nivolumab
+1 moreARCITECT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (botensilimab and balstilimab)Experimental Treatment2 Interventions
Arm A subjects will receive 2 cycles of induction treatment with each cycle lasting 6 weeks. Cycle 1 will consist of botensilimab 75mg IV in combination with balstilimab 450mg IV on Day 1 and Day 22. Cycle 2 will consist of balstilimab 450mg IV ONLY on Day 1 and Day 22. Botensilimab will NOT be given in Cycle 2. Subjects will receive 7 cycles of maintenance treatment with each cycle lasting 12 weeks. Cycles 3 and 4 will consist of botensilimab 75mg IV on Day 1 in combination with balstilimab 450mg IV on Day 1, 22, 43 and 64. Cycles 5-9 will consist of balstilimab alone 450 mg IV on Day 1, 22, 43 and 64.
Group II: Arm B (ipilimumab and nivolumab)Active Control2 Interventions
Arm B subjects will receive 2 cycles of induction treatment with each cycle lasting 6 weeks. Cycle 1 and 2 will consist of ipilimumab 1 mg/kg IV and nivolumab 3 mg/kg on Day 1 and 22. Subjects will receive 7 cycles of maintenance treatment with each cycle lasting 12 weeks. Nivolumab 480mg IV will be given on Day 1, 29 and 57 of each cycle (every 4 weeks).
Find a Location
Who is running the clinical trial?
Michael B. Atkins, MDLead Sponsor
1 Previous Clinical Trials
164 Total Patients Enrolled
Agenus Inc.Industry Sponsor
51 Previous Clinical Trials
4,615 Total Patients Enrolled
Georgetown UniversityOTHER
343 Previous Clinical Trials
136,382 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have been categorized as having a low, medium, or high risk of the cancer getting worse based on certain clinical factors.I don't expect to need any other cancer treatment while in this trial.I have been treated with specific immune or targeted therapies before.I have not received a live vaccine within the last 30 days.I haven't had active cancer in the last 2 years, except for certain curable types.I have lasting side effects from previous treatments that are moderate or worse.I have not had an infection needing treatment in the last 14 days.I am legally recognized as unable to make my own decisions.I have been on steroids or other immune-weakening drugs in the last 2 weeks.My doctor says my adrenal gland disorder is not under control.I have had a transplant, but not of the cornea.My cancer can be measured on scans and hasn't just been treated with radiation unless it's growing.Women who can have babies need to have a negative pregnancy test within a week before starting the study.I have received treatment for kidney cancer that was intended to prevent its return.I have not had major surgery in the last 4 weeks.I am 18 years old or older.My recent tests show my organs are functioning well.I agree to use birth control if I'm sexually active with women who can become pregnant.I have not had radiotherapy in the last 2 weeks.I am HIV positive with a CD4 count over 200 or an undetectable viral load.I have a tissue sample from my cancer, taken within the last year.I do not have serious heart conditions or recent major heart or stroke events.I can care for myself and am up and about more than 50% of my waking hours.I have confirmed active brain metastases.I have had severe allergic reactions to certain cancer treatments or have uncontrolled asthma.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My kidney cancer is confirmed and cannot be cured with surgery or radiation.If you have hepatitis B, you can join if tests show that the virus is not active. If you have hepatitis C, you can join if tests show that the virus is not active.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (botensilimab and balstilimab)
- Group 2: Arm B (ipilimumab and nivolumab)
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.
Has the FDA granted approval for Arm A, consisting of botensilimab and balstilimab?
"There is some clinical evidence to suggest the safety of Arm A (botensilimab and balstilimab), so it received a rating of 2. As this is only Phase 2, efficacy data has yet to be discerned."
Answered by AI
Does this experiment require additional participants?
"Affirmative. Data published on clinicaltrials.gov verifies that recruitment for this medical investigation, which was initially posted on September 1st 2023, is currently underway. In total, 120 patients must be drawn from 1 location to complete the trial."
Answered by AI
What is the enrollment capacity of this particular research project?
"Affirmative. Information documented on clinicaltrials.gov states that this experiment is currently enrolling participants, having been first announced on September 1st, 2023 and last edited eight days later. The study requires 120 patients at a single site to complete the trial."
Answered by AI
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