What side effects are associated with this type of intervention?

Immune checkpoint inhibitors targeting CTLA4 and PD1, such as ipilimumab and nivolumab, commonly cause side effects like fatigue, rash, diarrhea, and endocrine disorders (e.g., hypothyroidism). Severe but less common side effects include pneumonitis, hepatitis, colitis, and myocarditis, resulting from the immune system attacking normal tissues.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of kidney cancer, particularly those targeting CTLA4 and PD1 pathways. Notably, Ipilimumab (anti-CTLA4) and Nivolumab (anti-PD1) have been approved for use in combination for advanced renal cell carcinoma, demonstrating improved outcomes in clinical trials such as CheckMate 214. Additionally, Pembrolizumab (anti-PD1) has been approved in combination with Axitinib (a VEGFR inhibitor) for first-line treatment of advanced renal cell carcinoma, as evidenced by the KEYNOTE-426 study. These approvals highlight the efficacy of immune checkpoint inhibition in managing advanced kidney cancer.

What other types of research exist?

Promising alternatives to Botensilimab and Balstilimab for kidney cancer patients include: 1) Nivolumab plus Ipilimumab, which has shown durable long-term responses and potential for treatment-free intervals. 2) Pembrolizumab plus Axitinib, which has demonstrated efficacy in advanced renal cell carcinoma. 3) Cabozantinib in combination with Atezolizumab, which has shown positive results in clinical trials. These alternatives target immune checkpoints and angiogenesis pathways, offering effective treatment options.

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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

Must not have

Expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection)

Prior treatment with an anti-PD1 or anti-PDL1 agent, anti-CTLA4 antibody or a VEGFR TKI or anti-VEGF antibody including in the adjuvant setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two new drugs, botensilimab and balstilimab, in patients with advanced kidney cancer who haven't been treated before. The new drugs aim to help the immune system better recognize and attack cancer cells. The study will compare these treatments over several months.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My kidney cancer is confirmed and cannot be cured with surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't expect to need any other cancer treatment while in this trial.

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I have been treated with specific immune or targeted therapies before.

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I have lasting side effects from previous treatments that are moderate or worse.

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I am legally recognized as unable to make my own decisions.

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I have had a transplant, but not of the cornea.

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I have not had major surgery in the last 4 weeks.

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I have not had radiotherapy in the last 2 weeks.

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I do not have serious heart conditions or recent major heart or stroke events.

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I have confirmed active brain metastases.

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I have had severe allergic reactions to certain cancer treatments or have uncontrolled asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 12Eligibility criteria met

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

Immune checkpoint inhibitors, such as botensilimab (targeting CTLA4) and balstilimab (targeting PD1), work by blocking proteins that prevent the immune system from attacking cancer cells. By inhibiting these checkpoints, these drugs enhance the immune system's ability to recognize and destroy cancer cells. This mechanism is particularly important for kidney cancer patients as it can lead to improved treatment outcomes by leveraging the body's own immune response to fight the cancer more effectively.