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    Clinical Trials

    Leaders in Oncology Research

    We take pride in being a leader in the field of oncology research. At Northwest Cancer Centers this includes access to Phase I–III clinical trials and biomarker-driven precision medicine studies conducted in collaboration with national and global research sponsors. Through these trials, Northwest Cancer Centers offers the most comprehensive community-based oncology research program in Northwest Indiana, providing access to: National Cancer Institute-supported trials, Global pharmaceutical-sponsored studies, & Precision medicine and biomarker-driven research.

     

    Affiliations

    Federal clinical research sponsored by the National Surgical Adjuvant Breast and Bowel Program (NSABP) for breast and colon cancer.

    Federal clinical research sponsored by the Gynecologic Oncology Group (GOG) for gynecological cancers.

    Phase II clinical trials sponsored by the Hoosier Oncology Group (HOG) for a variety of metastatic cancers.

    Phase III clinical trials sponsored by the Cancer Trials Support Unit (CTSU) supported by the National Cancer Institute.

     

    Research Partnerships

    In addition to national cooperative groups, Northwest Cancer Centers participates in global, multicenter clinical trials sponsored by leading pharmaceutical, biotechnology, and precision medicine organizations These partnerships provide patients with access to cutting-edge therapies, including immunotherapy, targeted therapies, and biomarker-guided treatments.

     

    Why Consider a Clinical Trial at NCC?

    Clinical trials at Northwest Cancer Centers provide patients with access to promising treatments that may not yet be widely available. Participants receive care from a specialized research team with close monitoring throughout every step of the process. Taking part in a clinical trial also offers the opportunity to contribute to important advancements in cancer care, while benefiting from a personalized approach that aligns with each patient’s individual goals and treatment plan.

    New to clinical trials?  Click below to learn the basics, including phases, risks, and benefits.                                      

    Is a Clinical Trial Right For You?  Click below to watch Dr. Shruti Singh discuss things to consider.

    Our Current Trials

    Explore currently available Phase I, Phase II, and Phase III clinical trials below.  (Listed alphabetically by disease state.)

    Breast: Signatera-Guided CDK4/​6 Inhibitor Therapy in Breast Cancer (SIGNAL-ER 101)

    Status: Active

    Trial Tags:   Phase II | National |  ctDNA-guided therapy

    Trial Number: NCT07214532 

    NIH Trial Summary: The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with intermediate-risk HR+/HER2- early-stage breast cancer. Based on ctDNA test results, participants will either start CDK4/6 inhibitor therapy in addition to hormone therapy or continue hormone therapy with ongoing ctDNA surveillance. This study will compare outcomes to historical controls from the NataLEE trial to determine whether ctDNA-guided timing maintains efficacy while reducing unnecessary treatment. Participants will be followed for up to 9 years with regular blood draws, hormone therapy, imaging as needed, and quality-of-life assessments. 
    Trial Sponsor: Natera

    Breast: Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)

    Status: Active

    Trial Tags: Phase III  | Global | Interventional

    Trial Number: NCT06492616

     NIH Trial Summary: The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
     Trial Sponsor:  Stemline
     

    Breast: Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer (Briacell)

    Status: Active

    Trial Tags: Phase III | National | Interventional

    Trial Number: NCT06072612

    NIH Trial Summary: This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
    Trial Sponsor: BriaCell

     

     

    Breast: A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

    Status:  ACTIVE-No Longer Enrolling New Patients  

    Trial Tags: Phase II | National | Interventional

    Trial Number: NCT06568692

    NIH Trial Summary: This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.
     Trial Sponsor : Processa

    Breast: A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

    Status: Active

    Trial Tags: Phase III | Global | Interventional

    Trial Number: NCT06393374 or MK-2870-012 

    NIH Trial Summary:  This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
    Trial Sponsor: Merck, Sharp, & Dohme
     

    Endometrial: A Phase III, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

    Status: ACTIVE-No Longer Enrolling New Patients

    Trial Tags: Phase III | Global | Interventional

    Trial Number: NCT05611931

    NIH Trial Summary: The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.
    Trial Sponsor: Karyopharm Therapeutics

     

    Leukemia (CLL): A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

    Status:  ACTIVE-No Longer Enrolling New Patients  

    Trial Tags: Phase III | Global | Interventional

    Trial Number: NCT06428019

    NIH Trial Summary: Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed.

    Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide.

    Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    NIH Trial Link: https://clinicaltrials.gov/study/NCT06428019

    Trial Sponsor: Abbvie

    Lymphoma: A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-4)

    Status:  ACTIVE-No Longer Enrolling New Patients 

    Trial Tags: Phase III | Global | Interventional

    Trial Number: NCT06508658

    NIH Trial Summary: B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition will be assessed.

    Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 360 adult participants with R/R DLBCL will be enrolled in approximately 165 sites across the world.

    Participants in arm A will receive subcutaneous (SC) injections of epcoritamab plus oral lenalidomide capsules (E-Len) for up to 12 cycles (each cycle is 28 days). Participants in arm B will receive intravenously (IV) infused R-GemOx for up to 4 cycles (each cycle is 28 days). Participants in arm C will receive SC injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    NIH Trial Link:   Study Details | NCT06508658 

    Trial Sponsor:  Genmab

    Lung: A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)

    Status: Active

    Trial Tags: Phase III | Global | Interventional

    Trial Number: NCT07361510

    NIH Trial Summary: TROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%. 

    NIH Trial Link:  https://clinicaltrials.gov/study/NCT07361510

    Trial Sponsor: BMS

    Lung: Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (EVOKE-SCLC-04)

    Status: Active

    Trial Tags: Phase III | Global | Interventional

    Trial Number: NCT06801834 or EVOKE-SCLC-04

    NIH Trial Summary: The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC).

    The primary objectives of this study are to compare the effect of SG to SOC on objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).

    NIH Trial Link: https://clinicaltrials.gov/study/NCT06801834

    Trial Sponsor: Gilead Sciences 

     

     

    Lung - Solid Tumor Cancers: An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors (Prosper)

    Status: Active

    Trial Tags: Phase I/II | Global | Interventional

    Trial Number: NCT06244771 

    NIH Trial Summary: The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.
    Trial Sponsor: Frontier Medicines  
     

    Ovarian: Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer (Rainfol)

    Status:  Active - No Longer Enrolling New Patients 

    Trial Tags: Phase III | Global | Interventional

    Trial Number: NCT06619236

    NIH Trial Summary: This phase 3 study will be conducted in different countries all over the world.

    The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.

    Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.

    All participants will receive active drug; no one will be given placebo.

    NIH Trial Link: https://clinicaltrials.gov/study/NCT06619236

    Trial Sponsor: Genmab 

     

    Pancreatic-Solid Tumor Cancers: An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors (Prosper)

    Status: Active

    Trial Tags: Phase I/II | Global | Interventional

    Trial Number: NCT06244771

    NIH Trial Summary: The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.
    Trial Sponsor: Frontier Medicines
     

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