NIR178 for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Melanoma+13 More
NIR178 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Melanoma
  • Urothelial Cancer
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Malignant Neoplasm of Pancreas
  • Head and Neck Cancer
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Colorectal Carcinoma
  • Castration
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • RCC, Renal Cell Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Every 12 weeks until end of study for at least 24 months from the start date of the study treatment

Baseline
Determine the overall response rate
Cycle 2 Day 1
Neoplasms
Month 24
Safety and tolerability of the NIR178 and PDR001 combination
Month 6
Pharmacokinetics: Area under plasma concentration versus time curve (AUC) (NIR178)
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) (PDR001)
Presence and/or concentration of anti-PDR001 antibodies
Week 40
Determine the duration of response (DoR)
Progression free survival (PFS)
Month 24
Determine the overall survival rate (OR)
Day 6
Peak plasma concentration- Cmax (NIR178)
Peak plasma concentration- Cmax (PDR001)
Plasma concentration Vs Time profiles (NIR178)
Plasma concentration Vs Time profiles (PDR001)
Time of maximum concentration observed- Tmax (NIR178)
Time of maximum concentration observed- Tmax (PDR001)
Month 6
Determine the disease control rate (DCR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Side Effects for

Phase I: 150 mg Fasted
100%Aspartate aminotransferase increased
100%Diarrhoea
100%Alanine aminotransferase increased
57%Decreased appetite
43%Abdominal distension
29%Cough
29%Ascites
29%Insomnia
29%Asthenia
29%Hypertension
14%Hernia
14%Tumour associated fever
14%Anaemia
14%Oesophageal varices haemorrhage
14%Haemorrhoids
14%Hypokalaemia
14%Musculoskeletal chest pain
14%Dyspnoea
14%Rash
14%Hyperglobulinaemia
14%Haemoptysis
14%Melaena
14%Nausea
14%Vomiting
14%Pain
14%Peripheral swelling
14%Pyrexia
14%Nasopharyngitis
14%Blood alkaline phosphatase increased
14%Weight decreased
14%Hyperphosphataemia
14%Malnutrition
14%Back pain
14%Scrotal oedema
14%Oropharyngeal pain
14%Pruritus
14%Leukopenia
This histogram enumerates side effects from a completed 2019 Phase 1 & 2 trial (NCT02325739) in the Phase I: 150 mg Fasted ARM group. Side effects include: Aspartate aminotransferase increased with 100%, Diarrhoea with 100%, Alanine aminotransferase increased with 100%, Decreased appetite with 57%, Abdominal distension with 43%.

Trial Design

4 Treatment Groups

NIR178 + PDR001
1 of 4
Part 3
1 of 4
NIR178 BID Intermittent + PDR001
1 of 4
Japanese safety run-in part
1 of 4

Experimental Treatment

317 Total Participants · 4 Treatment Groups

Primary Treatment: NIR178 · No Placebo Group · Phase 2

NIR178 + PDR001Experimental Group · 2 Interventions: PDR001, NIR178 · Intervention Types: Drug, Drug
Part 3Experimental Group · 2 Interventions: PDR001, NIR178 · Intervention Types: Drug, Drug
NIR178 BID Intermittent + PDR001Experimental Group · 2 Interventions: PDR001, NIR178 · Intervention Types: Drug, Drug
Japanese safety run-in partExperimental Group · 2 Interventions: PDR001, NIR178 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spartalizumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every 12 weeks until end of study for at least 24 months from the start date of the study treatment

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,694 Previous Clinical Trials
3,522,742 Total Patients Enrolled
44 Trials studying Melanoma
9,354 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with bladder cancer must have received a prior platinum-containing regimen or be ineligible for cisplatin.
If you are a male or female patient aged 18 years or older, you may give informed consent for the study.
Biopsy was collected ≤ 6 months before 1st dose of study treatment and available at the site.
You have not received immunotherapy since collection of biopsy.
Patients with head and neck cancer must have received a prior platinum-containing regimen.
Patients with renal cell carcinoma must have received a prior VEGF TKI.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.