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Tyrosine Kinase Inhibitor

Pembrolizumab +/− Axitinib for Renal Cell Carcinoma

Phase 2

Recruiting

Led By David Y Oh, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Histologically confirmed RCC with a clear cell component

At least 18 years of age on day of signing informed consent

Must not have

Female of childbearing potential who has a positive urine pregnancy test within 72 hours prior to allocation

Has had an allogenic tissue/solid organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well pembrolizumab with or without standard of care axitinib works in treating patients with clear cell kidney cancer that has spread.

Who is the study for?

Adults with advanced or metastatic clear cell kidney cancer who are undergoing surgery may join this trial. They should be in good physical condition, have a tumor that can be biopsied, and agree to use contraception if of childbearing potential. Exclusions include recent anti-cancer treatments, active infections, serious wounds, psychiatric issues affecting participation, pregnancy/breastfeeding intentions within 120 days post-treatment, prior PD-1/PD-L1 therapy or certain autoimmune diseases.

What is being tested?

The study is testing the effectiveness of pembrolizumab (an immune system booster) alone or combined with axitinib (a drug blocking enzymes promoting cancer growth) compared to standard care involving surgery followed by chemotherapy/radiation. The goal is to see if these drugs better control kidney cancer and reduce its return after surgery.

What are the potential side effects?

Pembrolizumab might cause immune-related reactions like inflammation in organs or skin rashes; axitinib could lead to high blood pressure or liver function changes. Both drugs may increase risks for infection and fatigue among other side effects.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer has been confirmed to have clear cells.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has spread beyond its original location.

Exclusion Criteria

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

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I am a woman who can have children and I had a positive pregnancy test recently.

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I have received an organ or tissue transplant from another person.

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I have or had lung inflammation treated with steroids.

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I am currently on medication for an infection.

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I have been diagnosed with HIV.

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I have an active TB infection.

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I have had a solid organ or bone marrow transplant.

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My high blood pressure is not well-managed despite taking medication.

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I am not eligible for surgery or targeted therapy for my condition.

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I have not experienced brain function issues in the last 6 months.

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I have previously received treatments targeting immune checkpoints.

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I have received systemic therapy for kidney cancer.

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My kidney cancer does not have clear cells.

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I have noticeable swelling in my abdomen.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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My cancer has spread to the bones but can't be measured by standard tests.

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I have active brain metastases or carcinomatous meningitis.

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I have a history of hepatitis B or an active hepatitis C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Proportion of participants with >= 2-fold increase in the number of tumor-infiltrating immune cells (TIICs)

Secondary study objectives

Disease-Free Survival Rate (DFS) for participants who obtain CR or PR/SD with R0 resection and are treated 1 year of pembrolizumab-based therapy

Incidence of treatment-related adverse events

Median DFS for participants who obtain CR or PR/SD with R0 resection and are treated 1 year of pembrolizumab-based therapy

+3 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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

Group I: Cohort B (Pembrolizumab + VEGF-TKI)Experimental Treatment4 Interventions

Preoperative treatment consists of 200 mg pembrolizumab IV on day 1 of each cycle, and 5mg axitinib (a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)) PO BID on days 1-42 of each cycle. Axitinib maybe titered in select patients after cycle 1. Treatment repeats every 21 days for up to 3 cycles (9 weeks). Within 14-21 days following the end of pre-operative treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion. Within 21-42 days after surgery, patients with an R0 or R1 resection receive 400 mg pembrolizumab and 1, 3, 5, 7 or 10 mg axitinib PO BID every 42 days for up to 9 cycles (1 year), and patients with an R2 resection receive pembrolizumab IV and axitinib PO BID every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

Group II: Cohort A (Pembrolizumab monotherapy)Experimental Treatment3 Interventions

Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks). Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion. Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 22Eligibility criteria met