Bringing clinical trial opportunities to community oncology
Clinical trials for oncology drugs in the community setting is an integral component of OPN’s comprehensive platform for cancer care. By coordinating access to these clinical trial opportunities, OPN is able to offer its patients the ability to participate in leading edge clinical research normally limited to a restricted population. By giving community oncology patients access to these trials, OPN will expand access to new and innovative therapies for many underserved communities, and ensure patients receive off-labeled treatments in an IRB-approved, safe and protected environment.
If you have any questions regarding the studies listed below, please contact Heather Lyon at 818.254.2526 or by email.
To view the full trial description please click on the NCT number for the particular trial.
| Diagnosis | Protocol Title | Patient Population | Key Inclusion | Key Exclusion | NCT Number |
|---|---|---|---|---|---|
| Brain | An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors. | Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis | – Stable or decreasing steroids 5 days prior to consent – Progression within 90 day must be outside radiation field or provonsenten by Bx/resection – Seizures must be controlled for 14 days prior to ICF | – Various previous Tx requirements – XRT of CNS lesions within 14 days before first dose – History of known lepomeningeal involvement | NCT06047379 |
| Breast | A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence (ELEGANT) * | Node-postive, ER+, HER2-, early breast cancer with high risk of recurrence | – Histologically confirmed ER+, HER- – Considered high risk of recurrence – Received at least 24 months but not more than 60 months of endocrine therapy | – Inflammatory breast cancer – History of invasive breast cancer – History of malignancy within 3 years | NCT06492616 |
| Breast | An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Letrozole Compared to CDK4/6 Inhibitor Plus Letrozole in Participants Over 18 Years of Age with HR+, HER2-, Advanced/Metastatic Disease * | HR+/HER2-, Locally Advanced or Metastatic Breast Cancer who have not received prior systemic anti-cancer treatment for advanced/metastatic disease | – Histologically confirmed locally advanced or metastatic breast cancer, not amenable to surgical resection or radiation therapy with curative intent – Documented ER and/or PR-positive tumor – Documented HER2 negative tumor – Previously untreated | – Current or past history of CNS metastases – Prior (neo)adjuvant endocrine therapy and/or CDK4/6i and had recurrence during or within 12 months after last dose | NCT06760637 |
| Breast | A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE)-STML-ELA-0222 | Estrogen Receptor Positive, HER-2 Negative, Metastatic Breast Cancer previously treated with a CDK4/6 inhibitor | – Multi-arm umbrella study – Chemotherapy naieve and 1 or 2 prior hormonal therapies in the metastatic setting, one of which was in combination with CDK4/6 inhibitor (except for Arm D). PIK3CA mutation + required for Arm A. | – Prior chemotherapy in met. setting * Arm A: Prior Tx with alpelisib or PI3K inhibitor. Prior h/o T1DM or uncontrolled T2DM * Arm B: Prior Tx with everolimus * Arm C: Prior Tx with Abemaciclib * Arm D: Prior Tx with CDK4/6 inhibitor | NCT05563220 |
| Colorectal | Phase 3 Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation * | Treatment-Naïve Subjects with Metastatic Colorectal Cancer with KRAS p.G12C Mutation | – Pathologically documented metastatic colrectal adenocarcinoma with KRAS p.G12C mutation – Central confirmation of KRAS p.G12C mutation – Measurable metastatic disease per RECIST v1.1 | –Active, untreated brain metastases –Leptomeningeal disease –Previous treatment with a KRAS p.G12C inhibitor | NCT06252649 |
| Colorectal | A randomized, open-label phase 3 study of amivantamab + FOLFIRI versus cetuximab/bevacizumab + FOLFIRI in participants with KRAS/NRAS and BRAF wildtype recurrent, unresectable or metastatic colorectal cancer who have received prior chemotherapy (OrigAMI-3) * | Patients with KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer who have received prior Chemotherapy | –Histologically confirmed adenocarcinoma of the colon or rectum. Recurrent, unresectable or metastatic disease –Diagnosed to have KRAS, NRAS and BRAF wild-type tumor –Measurable disease according to RECIST v1.1 | –Medical history of ILD/pneumonitis/pulmonary fibrosis –Prior exposure to irinotecan, any agents that target EGFR or MET | NCT06750094 |
| Colorectal | A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer * | First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer | –Histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer –Must have unresectable or metastatic disease –KRAS, NRAS, BRAF wild-type tumor | –History of interstitial lung disease (ILD)/pneumonitis/pulmonary fibrosis –Has a prior or concurrent second malignancy other than the disease under study | NCT06662786 |
| Gastric | A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer | Previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma | – HER2 positive tumor confirmed by central laboratory – Measurable disease as defined by RECIST v1.1 | – Malignant tumors within 2 years – Disease progression within 6 months – Previous treatment with HER2-target therapy – Active gastrointestinal bleeding – Presence of CNS metastases | NCT06532006 |
| Hemeologic | Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia * | Patients With Previously Untreated Chronic Lymphocytic Leukemia | –Diagnosis of CLL/SLL | – Known or suspected Richter's transformation or CNS involvement –Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura –Known bleeding disorders | NCT05963074 |
| Hemeologic | A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma * | Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) | –Histologically confirmed diagnosis of DLBCL –No prior treatment for DLBCL | –History of transformation of indolent disease to DLBCL –Diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma –Ann Arbor Stage I DLBCL –Active infection requiring systemic therapy | NCT06717347 |
| Hemeologic | A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma * | Patients with Relapsed/Refractory Follicular or Marginal Zone Lymphoma | –Histologically confirmed grade 1-3a FL or MZL –Previous treatment with 1 or more lines of systemic therapy including anti-CD20 agent –Need for systemic therapy for FL or MZL | –Transformation to aggressive lymphoma –Ongoing need for corticosteroid treatment –Clinically significant cardiovascular disease –Prior malignancy within past 2 years –Active fungal, bacterial, and/or viral infection that requires systemic therapy | NCT05100862 |
| Hemeologic | A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) * | Patients with Relapsed or Refractory Multiple Myeloma (RRMM) | –Documented diagnosis of Multiple Myeloma and measurable disease | –Progression during treatment or within 60 days of the last dose of a proteasome inhibitor | NCT05519085 |
| Hemeologic | A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) * | Patients with Relapsed or Refractory Multiple Myeloma (RRMM) | –Documented diagnosis of Multiple Myeloma and measurable disease | –Prior treatment with mezigdomide or carfilzomib –Previous allogeneic stem cell transplant or autologous stem cell transplant within 12 weeks of initiating study treatment | NCT05552976 |
| Hemeologic | A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy * | Patients with Newly Diagnosed Multiple Myeloma or Not Considered Candidate for High-Dose Chemotherapy with Autologous Stem Cell Transplant (ASCT) | –Documented diagnosis of Multiple Myeloma –Be newly diagnosed or not considered a candidate for high-dose chemo with autologous stem cell transplant | –Prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids –Myeloma Frailty index of ≥ 2 (unless score of 2 is based on age alone) | NCT05552222 |
| Hemeologic | A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD) * | Erythropoiesis-Stimulating Agent (ESA)-Naïve Participants who are Non-Transfusion Dependent (NTD) | –Documented diagnosis of Myelodysplastic Syndrome (MDS) that meets classification of very low, low or intermediate-risk disease –Not transfusion dependent –Erythropoiesis-stimulating agent naïve –Symptoms of anemia | –Secondary MDS –Known history of diagnosis of AML –History of: cerebrovascular accident, transient ischemic attack, deep venous thrombosis, pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis within 6 months | NCT05949684 |
| Liver | A Randomized Phase 2 Study of Casdozokitug with Toripalimab Plus Avastin in Participants with Unresectable and/or Locally Advanced or Metastatic HCC * | Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) | –Confirmed diagnosis of unresectable locally advanced or metastatic HCC –At least 1 measurable, untreated lesion per RECIST v1.1 | –Prior systemic therapy for HCC –Previously received an anti-IL-27 antibody or anti-IL-27 targeted therapy –Known fibrolamellar HCC histology, sarcomatoid HCC or mixed cholangiocarcinoma and HCC –Moderate or severe ascites | NCT06679985 |
| Lung | Phase 3, Open-label study of HLX10 Plus Chemotherapy (Carboplatin-Etoposide) in Comparison with Atezolizumab Plus Chemotherapy in Previously Untreated Patients with Extensive-Stage SCLC-HLX10-005-SCLC301 | Newly diagnosed Extensive Stage Small Cell Lung Cancer | – No prior systemic therapy for ES-SCLC. – Patients who received chemoradiotherapy for previous limited stage SCLC must be treated and have a treatment-free interval of at least 6 months | – Symptomatic brain metastasis | NCT05468489 |
| Lung | An Open-label, Multi-center, Global Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) | Locally Advanced or Metastatic NSCLC | –Not suitable for surgery or concurrent/ sequential radio-chemotherapy – Subjects without AGAs: treatment failure of ≥ 1 line, including at least PD-(L)1 antibody and platinum-based chemo – Subjects with AGAs: treatment failure of ≥ 1 line, including at least targeted therapy for driver gene alterations and platinum-based chemo | – Tumor containing components of SCLC, neuroendocrine carcinoma, sarcomatoid carcinoma – Previous tx targeting topoisomerase I (chemo or ADCs) | NCT06907615 |
| Lung | Randomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy | Advanced or Metastatic Non-Small Cell Lung Cancer with Resistance to Immune Checkpoint Inhibitor Therapy | – Pathologically confirmed Stage IV NSCLC – Resistance to an immune checkpoint inhibitor therapy | – Systematic autoimmune disease currently requiring treatment – History of organ transplant requiring immunosuppression – Active infection requiring antibiotic therapy | NCT06745908 |
| Lung | A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS) | Participants with epidermal growth factor receptor mutated (EGFRm) NSCLC | –Confirmed advanced or metastatic NSCLC that is not amenable to curative intent therapy –Epidermal growth factor resistance-mutation | –History of interstitial lung disease –Uncontrolled tumor related pain | NCT06667076 |
| Lung | A Phase IIIb, Randomized, Multicenter, Open-label Study to Assess the Efficacy of Durvalumab Plus Tremelimumab Versus Pembrolizumab in Combination With Platinum-Based Chemotherapy for FirstLine Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Non-Squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS * | Previously Untreated Patients with Metastatic Non-Small Cell Lung Cancer with Non-Squamous Histology with Mutations in STK11, KEAP1 or KRAS | –Histologically or cytologically documented Stage IV non-squamous NSCLC –Must have tumors with STK11 or KEAP1 or KRAS mutations –No prior chemotherapy or systemic therapy for metastatic NSCLC | –Any evidence of acute or uncontrolled diseases or history of allogenic organ transplant –Mixed small cell lung cancer and NSCLC histology | NCT06008093 |
| Lung | A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation * | Phase 2 portion: Advanced NSCLC with KRAS G12C muttation & any PD-L1 TPS who are candidates for 1st-line tx Phase 3 portion: Unresectable, locally advanced or metastatic squamous or non-squamous NSCLC with KRAS G12C mutation and PD-L1 TPS ≥ 50% who are candidates for 1st-line tx | Phase 2 –Histologically confirmed unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS Phase 3 –Histologically confirmed unresectable or metastatic squamous or non-squamous NSCLC with KRAS G12C mutation and PD-L1 TPS ≥ 50% –1 of the following CNS inclusion: no evidence of brain metastases, untreated brain metastases not needing immediate local therapy, previoulsy treated brain metastases not needing immediate local therapy | Phase 2 & 3 –Prior systemic therapy for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or therapy targeting KRAS G12C mutation (e.g. AMG 510) Phase 2 –Active brain metastases Phase 3 –Patients with CNS lesions must not have any untreated brain lesions > 1.0 cm in size, any brainstem lesions, ongoing use of systemic corticosteroids for control of brain lesion syptoms at total daily dose of > 10mg, and poorly controlled (>1/week) generalized or complex partial seizures | NCT04613596 |
| Lung | A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer * | Previously Untreated Advanced or Metastatic Non-squamous NSCLC | –Histologically confirmed stage IV non-squamous NSCLC –No prior systemic therapy for advanced disease –EGFR, ALK, ROS-1 negative | –SCLC or mixed SCLC/NSCLC histology or squamous cell carcinoma –Prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease | NCT06311721 |
| Lung | A Phase III, Open-label, Randomized, Active Controlled, Trial Evaluating Orally Administered BI 1810631 Compared with standard of Care as First-line Treatment in Patients with Unresectable, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) Harbouring HER2 Tyrosine Kinase Domain Mutations | Not previously treated Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) Harbouring HER2 Tyrosine Kinase Domain Mutations | – Documented human epidermal growth factor receptor 2 (HER2) mutation in the tyrosine kinase domain per local lab – No previous treatment for locally advanced or metastatic disease – Eligible to receive platinum-based doublet and pembrolizumab – Archieve tissue availabe for central testing | – Tumors with targetable alterations with apporoved available therapy | NCT06151574 |
| Lung | An Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR or Exon 19 deletion Mutations Only) | Locally Advanced or Metastatic NSCLC harboring a non-resistant uncommon EGFR mutation | – ≤ 1 prior line of chemotherapy | – Prior Tx with EGFR TKI | NCT05168566 |
| Melanoma | A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab vs. Relatlimab and Nivolumab in Subjects with Unresectable or Metastatic Melanoma * | Unresectable or Metastatic Melanoma | –Histologically confirmed unresectable Stage III or Stage IV melanoma –No prior systemic therapy for unresectable or metastatic melanoma | –Uveal, acral or mucosal melanoma –Ongoing or recent evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents –Prior immune checkpoint inhibitor therapy –Systemic immune suppression | NCT06246916 |
| Melanoma | A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared with OPDIVO® (Nivolumab) in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma * | Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma | –Histologically confirmed unresectable or metastatic melanoma –No prior systemic treatment for advanced disease –Measurable disease according to RECIST v1.1 | –Prior systemic anti-cancer therapy for melanoma –Known hypersensitivity to monoclonal antibodies -Active CNS metastases not previously treated | NCT06054555 |
| Pancreatic | A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma * | Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma | –Histologically or cytologically confirmed PDAC that is metastatic –No previous treatment for PDAC in the metastatic setting | –Previously treated for locally advanced, unresectable PDAC –History of brain or leptomeningeal metastases –Prior treatment with a CD73 antagonist or inhibitor | NCT06608927 |
| Prostate | A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge * | Patients with Metastatic Castration-Resistant Prostate Cancer | –Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or neuro-endocrine features –Evidence of metastatic disease –Prior treatment with androgen receptor pathway inhibitor | –Participants with impaired cardiac function or clinically significant cardiac disease –Brain metastases –Liver metastases | NCT06764485 |
| Solid Tumor | A Phase 1 Study of SGN-B6A in Advanced Solid Tumors * | Subjects who have Solid Tumors | –Disease indication –Histologically or cytologically confirmed metastatic or unresectable solid malignancy of an included tumor type | –History of another malignancy within 3 years before first dose –Known active CNS metastases –Carcinomatous meningitis | NCT04389632 |
| Solid Tumor | A Phase 1/2 study to evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation * | Patients with advanced solid tumors that have a KRAS G12C mutation | –Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation –Unresectable or metastatic disease | –Hisotry of intestinal disease or major gastric surgery or inability to swallow oral medications –Other active cancer | NCT03785249 |
*CBSC Trial