A Phase 2, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected advanced solid tumors and non-Hodgkin lymphoma (CNIR178X2201)

Phase 2

Completed

• Conditions: 10029107; Lymphnode cancer; melanoma; eoplasmata, maligne, solide tumoren; breast cancer; cancer of head- and neck; Lungcancer; pancreatic cancer; 10025320; Prostate cancer

• Registration Number: NL-OMON55643
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

• Males and females >=18 years of age.
• Histologically documented advanced or metastatic solid tumors or lymphoma.
- Part 1: histologically confirmed advanced or metastatic renal cell
carcinoma, pancreatic cancer, urothelial cancer, head and neck cancer,
non-Hodgkin lymphoma, microsatellite stable or mismatch repair colorectal
cancer, triple negative breast cancer or cutaneous melanoma (confirmed BRAF
V660E status) or mCRPC
- Part 2: histologically confirmed advanced or metastatic NSCLC (EGFR and ALK
genotype).
- Part 3: histologically confirmed advanced or metastatic TNBC
• Tumor amenable to biopsy. See protocol page 52 for details.
• Part 1 - 3 only: Patients (other than those with DLBCL) must previously have
received at
least 1 and no more than 3 prior lines of therapy for their disease.

• No prior immunotherapy, except for cutaneous melanoma, I/O pre-treated
head/neck ca, and TNBC patients enrolled in part 3. An additional tumor type
might be added based on data.
• Measurable disease.
• ECOG performance status 0, 1, 2.
Refer to section Protocol section 5.2 for more detailed information regarding
prior therapy per tumor type

Exclusion Criteria

• History of another primary malignancy. .
• Active or prior documented autoimmune disease within the past 2 years.
• History of interstitial lung disease or non-infectious pneumonitis.
• Ongoing or prior treatment with A2aR inhibitors. Patients previously treated
with A2aR inhibitors for non-oncologic indications may be considered for
enrollment on a case by case basis.
• More than 2 or 3 prior lines of therapy (depending on the tumor type)
• Clinical laboratory abnormalities (within 21 days before 1st dose): Absolute
neutrophil count <1.0 x 109/L - Platelet count <100 x 109/L (for lymphoma <75 x
109/L , Hemoglobin (Hgb) <9 g/dL (5,59 mmol/l), Creatinine > 1. x upper limit
of normal (ULN) - Total bilirubin >1.5 x ULN - ALT and AST (liver) >3 x ULN
• History or current cardiac disease indicating significant risk of safety such
as uncontrolled cardiac disease (see criterion 29 protocol section 5.3)
• Mean QTcF >470 ms.
• Current or prior use of immunosuppressive medication within 28 days before
the first dose of PDR001.
•Smoking must be discontinued at least 7 days prior to initiating study drug
administration; smoking cessation products may be used.
For more details see protocol section 5.3

Study & Design

• Study Type: Interventional
• Study Design: Not specified