Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com


Novartis Pharmaceuticals
+41613241111


Study Location:

Novartis Investigative Site
Sutton
Surrey
SM2 5PT


A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.

Recruiting

Open to: All Genders

Age: 18 Years - N/A

Medical Conditions

Non-small Cell Lung Cancer (NSCLC)
Triple Negative Breast Cancer (TNBC)
Pancreatic Ductal Adenocarcinoma (PDAC)
Colorectal Cancer Microsatellite Stable (MSS)
Ovarian Cancer
Renal Cell Carcinoma (RCC)


Study summary

The purpose of this study is to assess the safety, tolerability, and preliminary anti-tumor activity of experimental medication NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers


Key dates

The recruitment start and end dates are as follows:

Jul 2018

Jan 2022

Study type

Interventional

Intervention Type : Other
Intervention Name : NZV930
Intervention Description : NZV930, Specified dose on specified days, intravenous (IV)

Intervention Arm Group : NZV930 Monotherapy;NZV930 with NIR178 & PDR001 Triplet Therapy;NZV930 with NIR178 Doublet Therapy;NZV930 with PDR001 Doublet Therapy

Intervention Type : Other
Intervention Name : PDR001
Intervention Description : PDR001, Specified dose on specified days, intravenous (IV)

Intervention Arm Group : NZV930 with NIR178 & PDR001 Triplet Therapy;NZV930 with PDR001 Doublet Therapy

Intervention Type : Drug
Intervention Name : NIR178
Intervention Description : NIR178 Specified dose on specified days, Orally

Intervention Arm Group : NZV930 with NIR178 & PDR001 Triplet Therapy;NZV930 with NIR178 Doublet Therapy

Who can take part?

You can take part if:


Inclusion Criteria:

Adult men & women ≥ 18 years of age Histologically confirmed advanced malignancies with documented progression following standard therapy, or for whom, in the opinion of the investigator, no appropriate standard therapy exists.

Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. The patient must be willing to undergo a new tumor biopsy at screening and during treatment.

ECOG performance status 0-2 and in the opinion of the investigator, likely to complete at least 56 days of treatment.

Exclusion Criteria:

Symptomatic or uncontrolled Brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.

Patients with treated symptomatic brain metastases should be neurologically stable for 4 weeks post-treatment prior to study entry and at doses of ≤10 mg per day prednisolone or equivalent for at least 2 weeks before administration of any study treatment.

Patients who required discontinuation of treatment due to treatment-related toxicities with prior immunotherapy.

Patients previously treated with anti-CD73 treatment and/or adenosine receptor A2a (A2aR) inhibitors.

Active, previously documented, or suspected autoimmune disease within the past 2 years.

Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur should not be excluded. Additionally, patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.

History of or current drug-induced interstitial lung disease or pneumonitis grade ≥ 2.

Impaired cardiovascular function or clinically significant cardiovascular disease, including any of the following: Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2), uncontrolled hypertension or clinically significant arrhythmia Patients with corrected QT using the Fridericia's correction (QTcF) > 470 msec for females or >450 msec for males, on screening ECG or congenital long QT syndrome Acute myocardial infarction or unstable angina < 3 months prior to study entry History of stroke or transient ischemic event requiring medical therapy Symptomatic claudication Infection: HIV infection, Active HBV or HCV infection (per institutional guidelines). Patients with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed in the expansion but not in the escalation, Known history of tuberculosis Infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed treatment before screening is initiated.

Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 6 weeks is indicated as washout period. For patients receiving anticancer immunotherapies, 4 weeks is indicated as the washout period.

Systemic chronic steroid therapy (≥ 10 mg/day prednisone or equivalent) or any immunosuppressive therapy, other than replacement dose steroids in the setting of adrenal insufficiency, within 7 days of the first dose of study treatment. Topical, inhaled, nasal, and ophthalmic steroids are allowed

Other protocol-defined inclusion/exclusion criteria may apply




You may not be able to take part if:

This is in the inclusion criteria above


Where can I take part?

Below are the locations for where you can take part in the trial.

  • Novartis Investigative Site
    Sutton
    Surrey
    SM2 5PT

Contact information

Novartis Pharmaceuticals
+41613241111


Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com


Funders/Sponsors


The study is sponsored by Novartis Pharmaceuticals .



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.

Is this study information helpful?

What will you do next?


Read full details

for Trial ID: NCT03549000

Last updated

This page is to help you find out about a research study and if you may be able to take part

The information is provided by researchers and we rely on them to keep it up-to-date. You can see more information by clicking on the 'Read full details' link above.

To take part, please print or share the study information with your GP/healthcare provider or contact the research team directly.