Moffitt logo

Clinical Trials Search

Clinical Trial 19228

Cancer Type: Thoracic
Interventions:NIR178; Not Applicable; PDR001

Study Type: Treatment
Phase of Study: Phase II

  • Alberto Chiappori

Call 813-745-6100
or 1-800-679-0775

Study Title

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


The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.


Primary: Part 1:To evaluate the efficacy of NIR178 and PDR001 combination in patients with selected advanced solid tumors and diffuse large B cell lymphoma (DLBCL). Part 2: To assess the efficacy several intermittent dosing schedules of NIR178 in combination with PDR001 in NSCLC. Part 3: To evaluate efficacy of intermittent dosing schedule of NIR178 in NSCLC and another tumor type. Secondary: - To assess efficacy of NIR178+PDR001 in select advanced solid tumors and lymphoma. - To assess the safety and tolerability of the NIR178 and PDR001 combination. - To characterize changes in the immune infiltrate in tumors. - To characterize the pharmacokinetics (PK) of NIR178, its metabolite NJI765 and PDR001 in combination. - To assess immunogenicity of PDR001. Exploratory: - To assess the pharmacodynamic (PD) effect of NIR178 alone and in combination with PDR001 in tumor tissue and peripheral blood. - To assess potential predictors of efficacy of NIR178 in combination with PDR001.

Inclusion Criteria

  • Male or female patients ≥18 years of age.
  • Histologically documented advanced or metastatic solid tumors or lymphomas
  • Part 1: histologically confirmed renal cell carcinoma (RCC), pancreatic cancer, urothelial cancer, head and neck cancer, diffuse large B-cell lymphoma (DLBCL), microsatellite stable (MSS) colon cancer, triple negative breast cancer (TNBC) or melanoma
  • Part 2: histologically confirmed diagnosis of advanced/metastatic NSCLC. For those with mixed histology, there must be a predominant histology
  • Part 3: histologically confirmed diagnosis of advanced/metastatic NSCLC and one additional tumor type based on emerging data from part 1 of the study.
  • Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and again during therapy on this study.
  • Part 1 - 3: 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, specifically including the following, unless considered inappropriate for the patient (e.g., safety concern, label contraindication): Patients with NSCLC must have received a prior platinum-based combination; Patients with EGFR positive NSCLC with a T790M mutation must have progressed on osimertinib or discontinued due to toxicity; Patients with head and neck cancer must have received a prior platinum-containing regimen; Patients with bladder cancer must have received a prior platinum-containing regimen or be ineligible for cisplatin; Patients with renal cell carcinoma must have received a prior VEGF tyrosine kinase inhibitor (TKI); Patients with MSS colorectal cancer must have received (or be intolerant to) prior therapy with fluoropyrimidine-oxaliplatin- and irinotecan- based regimens; Patients with triple negative breast cancer must have received a prior taxane-containing regimen.
  • Patients with DLBCL should be limited to those with no available therapies of proven clinical benefit
  • Should have had prior autologous hematopoietic stem cell transplantation (auto-HSCT) or determined to be ineligible for auto-HSCT.
  • Must not have received prior immunotherapy (previous immune checkpoint inhibitors; single agent and/or combination therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1), except for NSCLC patients enrolled in part 3 and Japanese safety run-in part.
  • Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral computer tomography (CT) scan, Magnetic Resonance Imaging (MRI), or calipers by clinical exam.
  • Other protocol-defined inclusion criteria may apply.

  • Exclusion Criteria

  • Ongoing or prior treatment with A2aR inhibitors. Patients previously treated with A2aR inhibitors for non-oncologic indications (e.g., Parkinson's disease) may be considered for enrollment on a case by case basis.
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of PDR001, with the exception of intranasal/inhaled corticosteroids or systemic corticosteroids at physiological doses (not exceeding equivalent of 10 mg/day of prednisone) History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of study drug and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated carcinoma in situ without evidence of disease Active or prior documented autoimmune disease within the past 2 years. Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
  • More than 3 prior lines of therapy. History of interstitial lung disease or non-infectious pneumonitis
  • Participation in another clinical study with an investigational product during the last 21 days prior to starting on treatment.
  • Other protocol-defined exclusion criteria may apply.