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Monoclonal Antibodies

Axitinib + Anti-OX40 Antibody for Kidney Cancer

Phase 2

Waitlist Available

Led By Sarmad Sadeghi

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Zubrod performance status of =< 2

Metastatic RCC

Must not have

Concurrent use of specific medications or substances

Prior malignancy active within the previous 3 years except for locally curable cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 180 days

Awards & highlights

Approved for 5 Other Conditions

Summary

This trial is studying axitinib with or without anti-OX40 antibody to treat patients with kidney cancer.

Who is the study for?

This trial is for adults with metastatic kidney cancer who've had a nephrectomy, have measurable disease, and proper organ function. They must not be pregnant or breastfeeding, use effective contraception, and can't have brain metastases requiring steroids, active autoimmune diseases, recent major surgeries or certain medical conditions.

What is being tested?

The study tests axitinib alone versus in combination with anti-OX40 antibody PF-04518600 to see which is better at treating metastatic kidney cancer. Axitinib blocks enzymes needed for tumor growth; the antibody may stimulate the immune system to fight cancer cells.

What are the potential side effects?

Potential side effects include immune-related reactions that could affect various organs, high blood pressure due to axitinib's effect on blood vessels, fatigue from both treatments affecting energy levels, and possible digestive issues like diarrhea.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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My kidney cancer has spread to other parts of my body.

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I am a man using highly effective birth control.

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My kidney cancer is mostly made up of clear cells.

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I have had a kidney removal surgery and can provide the tissue sample.

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My kidney function is within the normal range.

Exclusion Criteria

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

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I am currently taking certain medications.

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I haven't had any cancer except for treatable ones in the last 3 years.

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I have had a severe reaction to immune therapy.

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I do not have any active infections, including HBV, HCV, HIV, or AIDS.

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I have a condition or had surgery that affects how my body absorbs medication.

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I have an ongoing liver disease.

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I have side effects from previous treatments that are not just hair loss and are still serious.

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I haven't had major surgery in the last 6 weeks or minor surgery in the last 4 weeks.

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I have had a severe allergic reaction to certain protein treatments or antibodies.

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I have a history of heart, brain, or lung conditions.

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I am not pregnant or breastfeeding.

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I am taking steroids for brain metastases symptoms.

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My adrenal gland disorder is not under control.

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I have been treated with an mTOR inhibitor or axitinib before.

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I have been treated with specific antibodies or drugs before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 180 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Incidence of unacceptable toxicity

ORR defined as either complete response or partial response occurring any time during treatment and assessed by RECIST 1.1 and immune-related RECIST (irRECIST) criteria

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (axitinib, anti-OX40 antibody PF-04518600)Experimental Treatment3 Interventions

Patients receive axitinib PO BID on days 1-14 and anti-OX40 antibody PF-04518600 IV over 60 minutes on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (axitinib, placebo)Active Control3 Interventions

Patients receive axitinib as in Arm I and placebo IV on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axitinib

FDA approved

0 / 21Eligibility criteria met