Clinical Trials Actively Recruiting

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below.

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Results 1 - 10 of 172

A Phase 1a/b Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults with GRPR-Positive Advanced Solid Tumors (OMNIRAY)
Objective:

Phase 1a Dose Escalation and Optimization

Primary Objectives

Dose Escalation: To assess the safety and tolerability of LY4257496 monotherapy

Dose Optimization: To determine the optimal dose and schedule of LY4257496 monotherapy in ER+/HER2- BCa

Secondary Objectives

Dose Escalation and Optimization: To assess antitumor activity of LY4257496 monotherapy

Dose Escalation: To assess the biodistribution and radiation dosimetry of LY4257496

Dose Escalation: To characterize the PK properties of LY4257496

Phase 1b Dose Expansion/Optimization

Primary Objectives

Dose Expansion: To assess the antitumor activity of LY4257496

Dose Optimization: To determine the optimal dose and schedule based on safety and efficacy of LY4257496 monotherapy or in combination with SOC therapy

Secondary Objectives

Dose Expansion: To assess the safety and tolerability of LY4257496

Dose Expansion: To assess, for each Dose Expansion cohort, the antitumor activity of LY4257496
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic
Principal Investigator:
Shields, Anthony
Karmanos Trial ID:
2025-079
Age Group:
Adult
Phase:
Phase I
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A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Objective:

Primary Objectives:

Part 1b:

To determine the safety and tolerability of ZN-c3 in subjects with PROC

Part 2:

To investigate the antitumor activity of ZN-c3 in subjects with PROC

Secondary Objectives:

Part 1b:

To investigate the antitumor activity of ZN-c3 in subjects with PROC at different doses/schedules

To investigate the plasma PK of ZN-c3

Part 2:

To further investigate the antitumor activity of ZN-c3 in subjects with PROC

To investigate the safety and tolerability of ZN-c3 in subjects with PROC

To investigate the plasma PK of ZN-c3
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
GOG-3066
Age Group:
Adult
Phase:
Phase II
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A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) versus Treatment of Investigator's Choice in Patients with Platinum Resistant Ovarian Cancer
Objective:

Primary Objective:

To compare progression-free-survival (PFS) in patients with platinum-resistant ovarian cancer (PROC) receiving rinatabart sesutecan (Rina-S) versus investigator’s choice of therapy (IC).

Secondary Objectives:

To assess additional measures of efficacy of Rina-S compared to IC in patients with PROC.

To assess the safety of Rina-S compared to IC in patients with PROC

To assess potential changes in QTc associated with Rina-S

To assess patient reported outcomes in patients receiving Rina-S and IC
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Morris, Robert
Karmanos Trial ID:
GOG-3107
Age Group:
Adult
Phase:
Phase III
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A Phase 3, 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
Objective:

Primary Objectives:

To evaluate the efficacy of selinexor compared to placebo as maintenance therapy

Key Secondary Objectives:

To compare overall OS in selinexor and placebo arms

Secondary Objectives:

To evaluate the safety and tolerability of selinexor

To compare selinexor and placebo for time to first subsequent therapy

To compare selinexor and placebo for time to second subsequent therapy

To compare selinexor and placebo for time until second progression

To assess the efficacy of selinexor compared to placebo, as assessed by a blinded independent central review (BICR)

To evaluate health-related quality of life (HRQoL) outcomes
Cancer Categories:
Gynecologic
Principal Investigator:
Gogoi, Radhika
Karmanos Trial ID:
GOG-3083
Age Group:
Adult
Phase:
Phase III
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A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Haploidentical Related, Partially HLA-Mismatched, or Matched Unrelated Bone Marrow for Newly Diagnosed Patients with Severe Aplastic Anemia
Objective:

Primary Objective:

Estimate GVHD-free failure-free survival (GFFS) (a composite end point of survival without Grade III-IV aGVHD, cGVHD requiring immunosuppression, or primary or secondary graft failure requiring second definitive therapy) at 1 year after initiation of conditioning. GFFS will be evaluated separately for each transplant cohort.

Secondary Objectives:

Estimate OS at 1 year after initiation of conditioning.

Estimate FFS (a composite end point of survival without initiation of treatment with a second definitive therapy for curative intent) at 1 year after initiation of conditioning.

Estimate the probability of being engrafted (i.e., without primary or secondary graft failure) and alive at 1 year after initiation of conditioning.

Estimate the cumulative incidences of neutrophil recovery at Day +28 and Day +56 post-HSCT, platelet recovery at Day +100 post-HSCT, and red blood cell recovery at Day +100, Day +180, and Day +365 post-HSCT.

Estimate the cumulative incidences of primary, secondary, and any graft failure at 1 year post-HSCT.

Estimate the hematologic response classification according to the NIH criteria at Day +100, Day +180, and Day +365 post-HSCT.

Estimate the cumulative incidences of Grade II-IV and Grade III-IV aGVHD at Day +100 post-HSCT.

Estimate the cumulative incidences of all cGVHD and cGVHD requiring immunosuppression at 1 year post-HSCT.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Uberti, Joseph
Karmanos Trial ID:
BMTCTN2207
Age Group:
Adult
Phase:
Phase II
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A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score
Objective:

Primary Objective:

To determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Secondary Objectives:

To determine whether ACT added to OFS plus ET is superior to OFS plus ET in improving invasive disease-free survival (IDFS) among premenopausal, EBC patients with ER-positive, HER2-negative tumors and 21-gene RS between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

To determine whether ACT added to OFS plus ET is superior to OFS plus ET in improving overall survival (OS) among premenopausal, EBC patients with ER-positive, HER2-negative tumors and 21-gene RS between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

To determine whether ACT added to OFS plus ET is superior to OFS plus ET in improving distant recurrence-free interval (DRFI) among premenopausal, EBC patients with ER-positive, HER2-negative tumors and 21-gene RS between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

To determine whether ACT added to OFS plus ET is superior to OFS plus ET in improving breast cancer-free interval (BCFI) among premenopausal, EBC patients with ER-positive, HER2-negative tumors and 21-gene RS between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

To determine whether patients who receive ACT added to OFS plus ET will have more severe menopausal symptoms, measured by the FACT ESS-19 score, compared to those who do not receive ACT.

To determine whether patients who receive ACT added to OFS plus ET will have increased pain during aromatase inhibitor (AI) therapy compared to patients who do not receive ACT.

Cancer Categories:
Breast
Principal Investigator:
Arjyal, Lubina

Karmanos Trial ID:
NRG-BR009

Age Group:
Adult

Phase:
Phase III
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A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients with Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)
Objective:

Primary Objective:

To compare overall survival (OS) between proton craniospinal irradiation (pCSI) and involved-field radiotherapy (IFRT) in patients with breast cancer or non-small cell lung cancer (NSCLC) leptomeningeal metastasis.

Secondary Objectives:

To compare central nervous system progression-free survival (CNS PFS) between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis.

To compare time to CNS progression between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis.

To compare CNS PFS between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis, as evaluated by central review of imaging.

To compare the rate of radiation-induced central nervous system necrosis between pCSI vs. IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis.

To characterize treatment-related adverse events using CTCAE v5.0.

To compare patient-reported outcomes (Symptoms Severity subscale per MDASI-BT and MDASI-SP) in patients with breast cancer or non-small cell lung cancer leptomeningeal metastasis
Cancer Categories:
Breast,Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-BN014
Age Group:
Adult
Phase:
Phase III
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A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of Intermediate Fit Comparing Upfront Three-Drug Induction Regimens Followed by Double- or Single-Agent Maintenance
Objective:

Dual Primary Objectives:

To compare progression-free survival (PFS) in frail or selected intermediate fit
Newly Diagnosed Multiple Myeloma (NDMM) participants treated with VRd-Lite
induction followed by Lenalidomide maintenance (Arm 1) versus DRd induction
followed by Lenalidomide maintenance (Arm 2).

To compare overall survival (OS) in frail or selected intermediate fit NDMM
participants treated with VRd-Lite induction followed by lenalidomide maintenance
(Arm 1) versus DRd induction followed by lenalidomide and daratumumab and
hyaluronidase-fihj maintenance (Arm 3).

Secondary Objectives

To compare PFS in Arm 1 versus Arm 3

To compare OS in Arm 1 versus Arm 2.

To compare OS in Arm 2 versus Arm 3, contingent upon significant results from both dual primary endpoints in favor of the respective experimental arms.

To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3.

To assess the safety of Arm 1 with the safety of Arm 2 and Arm 3.

To explore veinous and arterial thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms.

To describe median time to response (CR or better per IMWG criteria, VGPR or better per IMWG criteria, PR or better per IMWG criteria) on the three study arms.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Cole, Craig
Karmanos Trial ID:
S2209
Age Group:
Adult
Phase:
Phase III
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A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (A Conjugated Anti-Cd22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL
Objective:

Primary objectives

Confirmation of tolerability: To confirm tolerability of the combination regimen with the addition of inotuzumab ozogamicin to the pediatricinspired regimen of CALGB 10403.

Phase III: To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, without censoring for transplant.

Secondary objectives

To determine the impact of inotuzumab ozogamicin on diseasefree (DFS) and overall survival (OS) in patients who achieve an induction response.

To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, with censoring for transplant.

To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS.

To determine the prognosis based on patients’ LDA gene signature in terms of EFS, DFS, and OS after treatment with or without inotuzumab ozogamicin when added to the C10403 backbone regimen.

To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of CALGB 10403.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Yang, Jay
Karmanos Trial ID:
A041501
Age Group:
Adult
Phase:
Phase III
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A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (DARA-VCD) Induction Followed by Autologous Stem Cell Transplant or DARA-VCD Consolidation and Daratumumab Maintenance in patients with Newly Diagnosed AL Amyloidosis
Objective:

Primary Objective:

To compare major organ deterioration progression-free survival between participants randomized to the ASCT and non-ASCT arms of this study.

Secondary Objectives

To compare overall survival (OS) between participants randomized to the ASCT and non-ASCT arms of this study.

To compare rates of cardiac and renal organ responses between participants randomized to the ASCT and non-ASCT arms of this study.

To compare rates of cardiac and renal organ progression between participants randomized to the ASCT and non-ASCT arms of the study.

To compare the frequency and severity of toxicities between participants randomized to the ASCT and non-ASCT arms of this study.

To compare minimal residual disease (MRD) negativity rates between participants randomized to the ASCT and non-ACST arms of this study.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Kin, Andrew
Karmanos Trial ID:
S2213
Age Group:
Adult
Phase:
Phase III
Learn More

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