What is a Clinical Trial?
Clinical trials are research studies designed to evaluate experimental treatments and procedures. Most breakthroughs in the diagnosis, treatment, and care of patients with cancer exist because of clinical trials. Clinical trials have specific treatment plans with specific eligibility criteria. Criteria differ from study to study, and are frequently based on age, sex, type/stage of cancer, medical history, and current health status. Participation in a trial requires the ability to travel to the clinical trial center (in this case, the Saint John’s Cancer Institute).
Search for Open Clinical Trials at Saint John’s Cancer Institute.
Questions?
For more information about any of our clinical trials, or general questions, please call our main hotline. See Clinical Trials FAQs for additional information.
Please call, 310-582-7448 to participate in a clinical trial
The clinical trials listed below represent active and enrolling trials. We implement, initiate, and oversee clinical trials here, at Saint John’s Cancer Institute, as well as other facilities in the Southern California region.
Trials by Cancer Type
What is it like to participate in a clinical trial?
Mark Perzley is interviewed by Saint John’s Cancer Institute in Santa Monica, California.
Saint John’s Experts Explain the Importance of Clinical Trials
Doctors, Kim Margolin, Santosh Kesari, Przemyslaw Twardowski, Parvin Peddi, Leland Foshag, and Emma Chacon deep dive into clinical trials and their significance to their patients and others.
Active Trials for 2026
Neuro-Oncology Clinical Trials – Summary
Saint John’s Cancer Institute is enrolling patients in a variety of neuro-oncology clinical trials targeting gliomas, glioblastomas, CNS lymphomas, and chordomas. These studies investigate novel therapies such as ONC201, NanO2™, ketogenic diets, CA-4948, and immunotherapy combinations. Trials are sponsored by leading biotech firms and academic institutions, with eligibility based on tumor type, genetic mutations, prior treatments, and performance status.
Key Neuro-Oncology Trials
- NEO100 (Intranasal Perillyl Alcohol) in HGM
- Sponsor: NeOnc Technologies Holdings, Inc.
- PI: Dr. Naveed Wagle
- Indication: High-grade meningioma (HGM)
- Eligibility: Patients with recurrent or progressive high-grade meningioma; protocol-specific criteria apply
- NCT05023018
- NEO100 (Intranasal Perillyl Alcohol) in r/p IDH1m Glioma
- Sponsor: Chimerix
- PI: Dr. Naveed Wagle
- Indication: Recurrent or progressive grade III/IV IDH1-mutant glioma
- Eligibility: IDH1-mutant glioma; recurrent or progressive disease; protocol-specific criteria apply
- NCT02704858
- Ketogenic Diet vs Standard Diet in Glioblastoma
- Sponsor: Cedars-Sinai Medical Center
- PI: Dr. Naveed Wagle
- Indication: Newly diagnosed glioblastoma
- Eligibility: Within 2 months of diagnosis; no prior chemo/radiation; no lipid metabolism disorders
- NCT05708352
- CA-4948 in Refractory Primary CNS Lymphoma
- Sponsor: Curis
- PI: Dr. Naveed Wagle
- Indication: Relapsed/refractory primary CNS lymphoma
- Eligibility: No isolated intraocular PCNSL; BTKi-naive or experienced; KPS ≥ 60; ECOG 0–2
- NCT03328078
- Pembrolizumab + High-Dose Pemetrexed for Chordoma
- Sponsor: Saint John’s Cancer Institute (local study)
- PI: Dr. Naveed Wagle
- Indication: Progressive chordoma
- Eligibility: Progression within 6 months; ECOG 0–1; no chronic steroids >10 mg prednisone
- NCT06794645
Prostate Cancer Clinical Trials – Summary
Saint John’s Cancer Institute is actively enrolling patients in several prostate cancer clinical trials, ranging from early-stage to metastatic disease. These studies explore novel immunotherapies, radiopharmaceuticals, diagnostic imaging, and hormonal therapies. Trials are sponsored by leading pharmaceutical companies and research groups, with eligibility based on disease stage, prior treatments, and genetic markers such as HRRm mutations.
Key Prostate Cancer Trials
- AAA817 vs Standard of Care in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (PSMAcTION)
- Sponsor: Novartis Pharmaceuticals
- PI: Dr. Przemyslaw Twardowski
- Indication: PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)
- Eligibility: Adults ≥18 with PSMA-positive mCRPC; ECOG 0–2; prior androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy; disease progression on or after [¹⁷⁷Lu]Lu-PSMA targeted therapy; ≥1 metastatic lesion on imaging.
- NCT06780670
- Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (KLK2-PASenger)
- Sponsor: Janssen Research & Development, LLC
- PI: Dr. Przemyslaw Twardowski
- Indication: Metastatic castration-resistant prostate cancer (mCRPC)
- Eligibility: Adult male patients with confirmed prostate cancer, Metastatic castration-resistant disease (mCRPC), Progression after androgen receptor pathway inhibitor (ARPI) therapy, ECOG performance status 0–1
- NCT07225946
- JSB462 (Luxdegalutamide) + Abiraterone in mHSPC
- Sponsor: Novartis Pharmaceuticals
- PI: Dr. Przemyslaw Twardowski
- Indication: Metastatic hormone-sensitive prostate cancer (mHSPC)
- Eligibility: Patients with mHSPC; evaluates combination vs ARPI standard (abiraterone or enzalutamide)
- NCT06991556
- REGN5678 ± Cemiplimab in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Sponsor: Regeneron
- PI: Dr. Przemyslaw Twardowski
- Indication: mCRPC and other PSMA-expressing tumors
- Eligibility: ≥2 prior therapies; specific criteria for ccRCC; post-177Lu-PSMA-617 cohort requires ≥2 doses
- NCT03972657
- Long-Term Safety of 177Lu-vipivotide tetraxetan (AAA617)
- Sponsor: Novartis
- PI: Dr. Przemyslaw Twardowski
- Indication: Prostate cancer patients previously treated with AAA617 in Novartis trials
- Eligibility: Must have received AAA617 in a prior trial; condom use required for 14 weeks post-treatment
- NCT05803941
Non-Prostate Genitourinary Clinical Trials – Summary
This section includes trials for bladder cancer, focusing on novel intratumoral therapies. These studies are designed for patients undergoing surgery and exclude those with metastatic disease or autoimmune conditions.
Key Non-Prostate Genitourinary Trials
- Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer (ABLE-32)
- Sponsor: Ferring Pharmaceuticals
- PI: Przemyslaw W. Twardowski, MD
- Indication: Intermediate-risk non–muscle invasive bladder cancer (NMIBC)
- Eligibility: Adults with intermediate-risk NMIBC, Newly diagnosed or recurrent disease, Must meet AUA/SUO intermediate-risk criteria
- NCT06510374
- Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis (LUNAR)
- Sponsor: Ferring Pharmaceuticals
- PI: Przemyslaw W. Twardowski, MD
- Indication: Low-grade upper tract urothelial carcinoma (LG-UTUC)
- Eligibility: Adults with low-grade UTUC, Histologically confirmed upper tract urothelial carcinoma
- NCT06668493
- AU-011 Intratumoral Injection in Bladder Cancer
- Sponsor: Aura Biosciences, Inc.
- PI: Dr. Jennifer Linehan
- Indication: NMIBC or MIBC with planned TURBT or cystectomy
- Eligibility: No metastatic disease, autoimmune conditions, or coagulation issues; no active malignancies requiring treatment
- NCT05483868
Bladder Cancer Clinical Trials: Evaluation of High and Low-grade Cancer
Dr. Jennifer Linehan discusses bladder cancer clinical trails, and how some patients can benefit from new treatments as their first treatment.
Lung Cancer Clinical Trials – Summary
The Merck TroFuse 023 and TroFuse 007 studies explore investigational combinations involving two different drugs. One is an investigational antibody-drug conjugate (ADC) being studied for cancer treatment and the other an FDA approved immune checkpoint inhibitor. Conducted by the Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center, they will be managing the investigation and can provide eligibility information and enrollment guidance for interested patients.
Merck TroFuse 023 and TroFuse 007 studies at Roy and Patricia Disney Family Cancer Center: See additional information.
- Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
- Sponsor: Merck
- PI: Karlton Wong, MD
- Indication: Non-small Cell Lung Cancer
- Implementation: TroFuse 023 — After initial treatment: This study looks at experimental antibody-drug conjugate after chemotherapy plus an additional immune checkpoint inhibitor. Participants first receive standard treatment. The study then compares the two drugs and the immune checkpoint inhibitor alone to see which approach may help slow or stop the cancer.
- NCT ID: 06422143, Protocol: MK-2870-023, Phase : 3
- Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50%
- Sponsor: Merck
- PI: Karlton Wong, MD
- Indication: Non-small Cell Lung Cancer
- Implementation: TroFuse 007 — As part of first treatment: This study looks at experimental antibody-drug conjugate as part of your first treatment. It compares the use of the investigational antibody-drug conjugate and a checkpoint inhibitor, and the immune checkpoint inhibitor alone to see whether starting with the combination may help slow or stop the cancer.
- NCT ID: 06170788, Protocol, MK-2870-007, Phase: 3
Melanoma Clinical Trials – Summary
Saint John’s Cancer Institute is conducting several melanoma trials, including perioperative immunotherapy, biomarker-driven studies, and expanded access programs. These trials target both early-stage and advanced melanoma, with a focus on checkpoint inhibitors and novel combinations.
Key Melanoma Trials
- DECIDE: DecisionDx Impact on SLNB Decisions
- Sponsor: Castle Biosciences, Inc.
- PI: Dr. Richard Essner
- Indication: Newly diagnosed cutaneous melanoma
- Eligibility: Within 2 months of biopsy; excludes Stage III/IV or prior melanoma in same region
- [NCT not listed]
- IMC-F106C + Nivolumab vs Nivolumab Alone in Advanced Melanoma (PRISM-MEL-301)
- Sponsor: Immunocore
- PI: Dr. Kim Margolin
- Indication: Previously untreated, unresectable or metastatic melanoma
- Eligibility: HLA-A*02:01 positive; ECOG 0–1; measurable disease; prior adjuvant therapy allowed
- NCT061123141
Breast Cancer Clinical Trials – Summary
Saint John’s Cancer Institute offers a wide range of breast cancer clinical trials, including studies on triple-negative breast cancer (TNBC), HER2-positive disease, hormone receptor-positive cancers, and cognitive effects of treatment. These trials explore de-escalation strategies, novel drug combinations, imaging techniques, and supportive care interventions.
Key Breast Cancer Trials
- Pembrolizumab vs Observation After Pathologic Complete Response in Early-Stage Triple-Negative Breast Cancer (OptimICE-PCR) (PK)
- Sponsor: Alliance for Clinical Trials in Oncology
- PI: Dr. Sara Michell Tolaney
- Indication: Early-stage (Stage II–III) triple-negative breast cancer (TNBC) with pathologic complete response after neoadjuvant chemotherapy + pembrolizumab
- Eligibility: Age ≥18; Stage II–III TNBC at diagnosis; received ≥6 cycles of neoadjuvant chemotherapy with pembrolizumab; no residual invasive disease in breast or lymph nodes after surgery (residual DCIS allowed); no metastatic disease or recurrent disease./li>
- NCT05812807
- STX-478-101 (LY4064809) a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK)
- Sponsor: Eli Lilly and Company
- PI: Dr. Parvin Peddi
- Indication: Breast Cancer, Solid Tumors, Adult
- Eligibility: ≥18 years (adults only). Performance status: ECOG 0–1 (fully active or mildly limited), Locally advanced, metastatic, or unresectable cancer
- NCT05768139
- OptimICE-PCR: De-escalation in Early-Stage TNBC with pCR
- Sponsor: Cooperative Group Alliance
- PI: Dr. Janie Grumley
- Indication: TNBC with no residual invasive disease after neoadjuvant chemo + pembrolizumab
- Eligibility: Residual DCIS allowed; ≥6 cycles of neoadjuvant therapy
- NCT05812807
- NRG-C011: Cognitive Training for Cancer-Related Impairment
- Sponsor: Cooperative Group Alliance
- PI: Dr. Janie Grumley
- Indication: Stage I–III non-metastatic breast cancer
- Eligibility: PROMIS score <12; 6 months–5 years post-treatment
- NCT05896189
- TailorRT: Regional Radiotherapy in Biomarker Low-Risk Node-Positive Breast Cancer
- Sponsor: CCTG
- PI: Dr. Janie Grumley
- Indication: Non-metastatic invasive carcinoma with Oncotype DX ≤25
- Eligibility: T3N0, ER ≥1%, HER2-negative
- NCT03488693
- Bria-IMT + Checkpoint Inhibitor vs Physician’s Choice in Metastatic Breast Cancer
- Sponsor: BriaCell Therapeutics
- PI: Dr. Parvin Peddi
- Indication: Advanced MBC with no meaningful alternatives
- Eligibility: Persistent or metastatic disease; failed all approved regimens
- NCT06072612
- Inavolisib + Phesgo vs Placebo + Phesgo in PIK3CA-Mutated HER2+ mBC
- Sponsor: Hoffman-La Roche
- PI: Dr. Reva Basho
- Indication: PIK3CA-mutated HER2+ metastatic breast cancer
- Eligibility: Confirmed HER2+ and PIK3CA mutation
- NCT05894239
- Fulvestrant + Binimetinib in HR+ MBC with NF1 Alterations (ComboMATCH)
- Sponsor: National Cancer Institute (NCI)
- PI: Dr. Reva Basho
- Indication: HR+ MBC with NF1 mutations
- Eligibility: Prior CDK4/6 inhibitor; up to one line of chemo in metastatic setting
- NCT05554354
Other Solid Tumors Clinical Trials – Summary
These trials target a broad range of advanced or metastatic solid tumors, including MSI-H, TMB-H, and AKT-altered cancers. They explore immunotherapies, IL-2 superkines, and targeted agents in combination with chemotherapy.
Key Other Solid Tumor Trials
- BI 1831169 ± Ezabenlimab in Advanced Solid Tumors
- Sponsor: Boehringer Ingelheim
- PI: Dr. Naveed Wagle
- Indication: Metastatic or recurrent solid tumors
- Eligibility: At least one injectable lesion ≥10 mm; ECOG 0–1; no brain metastases or steroid use
- NCT05155332
- MDNA11 ± Checkpoint Inhibitor in Advanced Solid Tumors
- Sponsor: Medicenna
- PI: Dr. Przemyslaw Twardowski
- Indication: MSI-H, dMMR, TMB-H, melanoma, NMSC, or other IL-2/IO-sensitive tumors
- Eligibility: ECOG 0–1; no high-dose steroids; stable/treated brain metastases allowed
- NCT05086692
- Paclitaxel + Ipatasertib in AKT-Altered Non-Breast Solid Tumors (ComboMATCH)
- Sponsor: National Cancer Institute (NCI)
- PI: Dr. Reva Basho
- Indication: Advanced non-breast solid tumors with AKT alterations
- Eligibility: Progressed within 6 months of taxane-based therapy
- NCT05554380
Have questions?
For more information about any of our clinical trials, or general questions, please call our main hotline. See Clinical Trials FAQs for additional information.
Please call, 310-582-7448 to participate in a clinical trial
The clinical trials listed below represent active and enrolling trials. We implement, initiate, and oversee clinical trials here, at Saint John’s Cancer Institute, as well as other facilities in the Southern California region.