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A2aR Inhibitor

NIR178 for Kidney Cancer

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No immunotherapy was given to the patient since collection of biopsy.
Male or female patients ≥18 years of age. For Japan only: written consent is necessary both from the patient and his/her legal representative if he/she is under the age of 20 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.9 years (part 1), 4.7 years (part 2) and 0.5 years (part 3)
Awards & highlights

Study Summary

This trial is testing a new drug combo to treat various solid tumors and a type of lymphoma. They want to see if it's effective and safe, and also figure out the best way to give the drugs.

Eligible Conditions
  • Kidney Cancer
  • Pancreatic Cancer
  • Head and Neck Cancers
  • Non-Hodgkin's Lymphoma
  • Colorectal Cancer
  • Melanoma
  • Prostate Cancer
  • Non-Small Cell Lung Cancer
  • Bladder Cancer
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.9 years (part 1), 4.7 years (part 2) and 0.5 years (part 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.9 years (part 1), 4.7 years (part 2) and 0.5 years (part 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Overall Response Rate (ORR) Per Cheson 2014 for DLBCL
Part 1: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors
Part 2: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors
+1 more
Secondary outcome measures
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NIR178
All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NJI765 (NIR178 Metabolite)
All Study Parts: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001
+45 more

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739
58%
Diarrhoea
50%
Aspartate aminotransferase increased
42%
Hyperphosphataemia
33%
Pyrexia
33%
Anaemia
33%
Alanine aminotransferase increased
25%
Blood bilirubin increased
25%
Abdominal distension
25%
Fatigue
17%
Neutrophil count decreased
17%
Oedema peripheral
17%
Abdominal pain
17%
Nausea
17%
Nasopharyngitis
17%
Gamma-glutamyltransferase increased
17%
Arthralgia
17%
Back pain
17%
Rash
17%
Pruritus
17%
Hot flush
8%
Flank pain
8%
Oesophageal varices haemorrhage
8%
Dysgeusia
8%
Myalgia
8%
Tinea cruris
8%
Hyperglycaemia
8%
Liver carcinoma ruptured
8%
Oedema
8%
Blood creatinine increased
8%
Hypokalaemia
8%
Palpitations
8%
Abdominal discomfort
8%
Headache
8%
Constipation
8%
Vomiting
8%
Folliculitis
8%
Rash pustular
8%
Sinusitis
8%
Bilirubin conjugated increased
8%
Blood albumin decreased
8%
Blood creatine phosphokinase increased
8%
Blood phosphorus decreased
8%
Weight decreased
8%
Platelet count decreased
8%
Hyponatraemia
8%
Insomnia
8%
Dyspnoea exertional
8%
Peripheral sensory neuropathy
8%
Cough
8%
Dysphonia
8%
Epistaxis
8%
Pneumonitis
8%
Productive cough
8%
Dry skin
8%
Hyperthyroidism
8%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Patients of Combination Dose
Phase I: FGF401 120 mg + PDR001 300 mg
Phase I: 120 mg Fed
Phase I: 150 mg Fasted
Phase II: Group 1 - FGF401 120 mg QD
Phase II: Group 2 - FGF401 120 mg QD
Phase II: Group 3 - FGF401 120 mg QD
All Patients of Single Agent FGF401
Phase I: FGF401 80 mg + PDR001 300 mg
All Patients
Phase I: 50 mg Fasted
Phase I: 80 mg Fasted
Phase I: 80 mg Fed
Phase I: 120 mg Fasted

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 3Experimental Treatment2 Interventions
Further evaluation of optimal intermittent or continuous schedule of NIR178 in combination with PDR001 (if selected based on results of Part 2). A film-coated tablet of NIR178 was assessed.
Group II: NIR178 BID Intermittent + PDR001Experimental Treatment2 Interventions
Part 2: Three different dosing schedules of NIR178 twice daily (BID) including continuous and two intermittent in combination with PDR001
Group III: NIR178 + PDR001Experimental Treatment2 Interventions
Part 1: NIR178 continuously in combination with PDR001 400mg every 4 weeks. The part 1 enrolled 9 different tumor types.
Group IV: Japanese safety run-in partExperimental Treatment2 Interventions
Different dosing schedules of NIR178 were explored.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PDR001
2016
Completed Phase 2
~2700

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,274 Total Patients Enrolled

Frequently Asked Questions

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

How many clinical facilities are currently conducting this trial?

"This clinical trial is running in various locations, including the University of Wisconsin in Madison, WI; H Lee Moffitt Cancer Centre and Research Institute Inc. located near Tampa, FL; as well as Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins situated close to Baltimore, MD."

Answered by AI

Have any preceding investigations been conducted with NIR178?

"At present, there are 27 open clinical trials examining the efficacy of NIR178. Notably, one of these investigations has reached Phase 3 and is being conducted at locations across 508 cities, with several taking place in New york City."

Answered by AI

Is this the inaugural endeavor of its type?

"Presently, there are 27 energetic investigations for NIR178 across 35 countries and 122 cities. The inaugural trial of the drug was launched in 2011 by Novartis Pharmaceuticals and included 185 members; completing its Phase 1 endorsement stage. Subsequent to this foray, an additional 21 experiments have been accomplished."

Answered by AI

How many subjects are being recruited for participation in this clinical research?

"This investigation is no longer recruiting participants, having been posted on August 28th 2017 and last updated on November 25th 2022. For those looking for a related clinical trial, there are 4324 studies enrolling patients with melanoma as well as 27 trails involving NIR178 that still need volunteers."

Answered by AI

Are there opportunities for prospective participants to join this research?

"Clinicaltrials.gov data confirms that this study, posted on August 28th 2017 and last updated November 25th 2022, is not presently searching for participants. However, there are a plethora of other medical trials actively recruiting patients right now - 4351 to be exact."

Answered by AI

What potential adverse effects might patients experience with NIR178?

"NIR178's safety has been established to a degree, so it was assigned a score of 2 due to its status as being in the second phase of clinical trials and thus lacking efficacy data."

Answered by AI
~42 spots leftby Mar 2025