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ESK981 for Kidney Cancer (ERICA Trial)

Phase 2
Waitlist Available
Led By Ajjai Alva, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months after last dose of study treatment
Awards & highlights

ERICA Trial Summary

This trial is testing a new drug to see if it is effective in treating kidney cancer when used with another existing drug.

Eligible Conditions
  • Kidney Cancer

ERICA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months after last dose of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months after last dose of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1. The percentage of patients that respond to treatment with the combination of ESK981 monotherapy and nivolumab therapy (Cohort B).
Secondary outcome measures
2. The percentage of patients that respond to treatment with ESK981 monotherapy (Cohort A).
Duration of response
Duration of therapy
+2 more

Side effects data

From 2023 Phase 2 trial • 13 Patients • NCT03456804
31%
Fatigue
31%
Pain
31%
Back pain
23%
Gastrointestinal disorders - Other, specify
15%
Vascular disorders - Other, specify
15%
Cardiac disorders - Other, specify
15%
Weight loss
15%
Musculoskeletal and connective tissue disorder
15%
Diarrhea
15%
Hypertension
15%
Localized edema
15%
Pain in extremity
15%
Constipation
8%
Vomiting
8%
Urinary frequency
8%
Non-cardiac chest pain
8%
Aspartate aminotransferase increased
8%
Eye disorders - Other, specify
8%
Hyperglycemia
8%
Alanine aminotransferase increased
8%
Muscle weakness lower limb
8%
Nausea
8%
Dehydration
8%
Reproductive system and breast disorders - Othe
8%
Dizziness
8%
General disorders and administration site condi
8%
Generalized muscle weakness
8%
Headache
8%
Hematuria
8%
Hoarseness
8%
Hyponatremia
8%
Hypotension
8%
Insomnia
8%
Lymphedema
8%
Nervous system disorders - Other, specify
8%
Pelvic pain
8%
Sinusitis
8%
Lymphocyte count decreased
8%
Myocardial infarction
8%
Skin infection
8%
Anorexia
8%
Anxiety
8%
Bruising
8%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment ESK981

ERICA Trial Design

2Treatment groups
Experimental Treatment
Group I: ESK981 and NivolumabExperimental Treatment2 Interventions
ESK981: 160 mg (4 capsules) PO daily for 5 consecutive days followed by a 2-day off drug in each week, repeated weekly in 4-week (28-day) cycles Nivolumab: 480 mg/dose IV, Day 1 of each 28-day cycle
Group II: ESK981 MonotherapyExperimental Treatment1 Intervention
ESK981: 160 mg (4 capsules) PO daily for 5 consecutive days followed by a 2-day off drug in each week, repeated weekly in 4-week (28-day) cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
ESK981
2018
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,089 Total Patients Enrolled
Ajjai Alva, MDPrincipal InvestigatorRogel Cancer Center
3 Previous Clinical Trials
65 Total Patients Enrolled

Media Library

ESK981 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03562507 — Phase 2
Kidney Cancer Research Study Groups: ESK981 Monotherapy, ESK981 and Nivolumab
Kidney Cancer Clinical Trial 2023: ESK981 Highlights & Side Effects. Trial Name: NCT03562507 — Phase 2
ESK981 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03562507 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the FDA's current stance on ESK981?

"ESK981 falls into the category of a Phase 2 trial, which means that while there is evidence of its safety, there are no studies proving its efficacy. Our team rates it as a 2."

Answered by AI

Could you provide some context for ESK981's role in medical research?

"747 studies are currently underway to test the efficacy of ESK981 with 82 of them in Phase 3. These trials are being conducted all over the world, but most notably in Basel, BE and 40325 other locations."

Answered by AI

Have similar trials been conducted in the past?

"ESK981 has undergone 747 active studies since first being trialed in 2010. These studies have taken place across 2347 different cities and 50 countries. The original study, sponsored by Medarex, only involved 127 patients but it completed Phase 1 of the drug approval process. In the past 10 years, an additional 249 trials have been completed for this medication."

Answered by AI

Are there any current vacancies in this clinical trial for new patients?

"2665 other clinical trials for carcinoma, renal cell and 747 studies are still recruiting patients."

Answered by AI

What are the medical benefits of ESK981?

"ESK981 is a popular choice for treating malignant neoplasms. However, it has also shown efficacy in managing other conditions like unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

How many people can sign up for this research project?

"This study is not recruiting new patients at the moment, as noted by its posting date of April 11th, 2019 and last update on September 8th, 2021. If you are interested in other trials, 2665 studies for carcinoma, renal cell and 747 for ESK981 are actively looking for participants."

Answered by AI
~1 spots leftby Apr 2025