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 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, 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
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A Randomized Phase II trial of consolidation therapy following CD19 CAR T-cell treatment for Relapsed/Refractory Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma
Objective:

Primary Objectives:

To compare the progression-free survival in participants with relapsed/refractory
large B-cell lymphoma or follicular lymphoma grade 3B with stable disease (SD)
or partial remission (PR) on first imaging response by central review (day +30
PET/CT scan) after commercial CD19 CAR T-cell therapy who are randomized to
receive each consolidation therapy versus those that receive no consolidation
therapy (i.e. control). Specifically, to compare the PFS of 1) mosunetuzumab
consolidation to no consolidation, 2) polatuzumab vedotin consolidation to no
consolidation, 3) mosunetuzumab + polatuzumab vedotin to no consolidation

Secondary Objectives:

To compare overall survival (OS) in participants randomized to each consolidation
treatment arm versus control.

To compare the complete remission (CR) conversion rate up to one year in
participants randomized to each consolidation arm versus control.

To evaluate the treatment-related adverse events in participants randomized to
each consolidation arm.

To evaluate the association between total metabolic tumor volume (TMTV), SUV
max, and sum product (SPD) of diameters by PET-CT at first imaging response
with complete remission conversion up to one year in participants randomized to
each consolidation arm as well as those randomized to control.

To evaluate the overall response rate (ORR), CR rate, PFS, and OS of participants
randomized to Arm 4 (observation) who have lymphoma progression within 12
months of CAR T-cell infusion and subsequently ‘cross-over' to receive treatment
with mosunetuzumab + polatuzumab vedotin.

To estimate overall survival for all patients registered to this study.

To assess the difference in overall survival between participants who achieved CR
at first imaging (day +30) versus. those who did not achieve CR at first imaging.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Uberti, Joseph
Karmanos Trial ID:
S2114
Age Group:
Adult
Phase:
Phase II
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Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)
Objective:

Primary Objective:

De-Intensification Study:

To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with RT alone instead of 6 months ADT + RT experience non-inferior rate of distant metastasis.

Intensification Study:

To determine whether men with NCCN UIR prostate cancer who are in the higher genomic risk (Decipher score ≥0.40) will have a superior metastasis-free survival through treatment intensification with darolutamide added to the standard of RT plus 6 months ADT.

Secondary Objectives:

To compare overall survival (OS) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.

To compare time to PSA failure between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.

To compare metastasis free survival (MFS) based on conventional imaging between the standard of care (RT plus 6 months of ADT) and de-intensification intervention (RT alone).

To compare MFS based on either conventional and/or molecular imaging between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.

To compare cumulative incidence of locoregional failure based upon conventional imaging and/ or biopsy between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months ADT plus darolutamide) interventions.

To compare cumulative incidence of distant metastasis based upon conventional imaging between standard of care (RT plus 6 months of ADT) and intensification intervention (RT plus 6 months ADT plus darolutamide).

To compare cumulative incidence of distant metastasis based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.

To compare prostate cancer-specific mortality between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.

To compare sexual and hormonal related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.

To compare fatigue, as measured by the PROMIS-Fatigue instrument, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.

To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
Cancer Categories:
Genitourinary (GU)
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-GU010
Age Group:
Adult
Phase:
Phase III
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Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer
Objective:

Primary Objective:

To compare breast cancer event-free survival between participants randomized to standard of care neoadjuvant chemotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab.

Secondary Objectives:

To compare pathologic complete response rates (ypT0/is, ypN0) in participants randomized to standard of care chemotherapy alone vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab

To compare residual cancer burden distribution between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab

To compare distant relapse-free survival between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab

To compare overall survival between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab

To compare the frequency and severity of toxicities between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab among those who initiate the assigned treatment.
Cancer Categories:
Breast
Principal Investigator:
Elayoubi, Jailan
Karmanos Trial ID:
S2206
Age Group:
Adult
Phase:
Phase III
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Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial
Objective:

Primary Objective

Phase II:

To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone

Phase III:

To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone

Secondary Objectives

To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm

To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and >3 visible tumors

To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease (“complete consolidation”) and patients who do not receive consolidation radiation to all visible disease (“incomplete consolidation”)
Cancer Categories:
Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-LU007
Age Group:
Adult
Phase:
Phase II/III
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Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
Objective:

Co-Primary Objectives:

To compare the 3-year milestone progression free survival (PFS) probabilities in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm.

To compare progression free survival (PFS) in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm.

Secondary Objectives:

To compare overall survival (OS) between participants randomized to rituximab versus mosunetuzumab.

To compare overall response rates at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab.

To compare event free survival (EFS) between participants randomized to rituximab versus mosunetuzumab.

To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab.

To compare the restricted chance of longer PFS (2-6 years) between participants randomized to rituximab versus mosunetuzumab.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Modi, Dipenkumar
Karmanos Trial ID:
S2308
Age Group:
Adult
Phase:
Phase III
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Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
Objective:

Primary Objective:

To assess whether participants with early stage TNBC randomized to receive
anthracycline-free, taxane-platinum neoadjuvant chemotherapy with
pembrolizumab have non-inferior breast cancer event-free survival (BC-EFS)
compared to participants randomized to taxane-platinum-anthracycline
neoadjuvant chemotherapy with pembrolizumab.

Secondary Objectives:

To compare pathological complete response (pCR) and residual cancer burden
(RCB) rates by randomized arm.

To compare pCR and RCB rates between randomized arms by tumor infiltrating
lymphocytes (TIL) status.

To compare BC-EFS between randomized arms in the TIL-enriched and non-TIL
enriched subgroups.

To compare distant relapse-free survival and overall survival by randomized arm.

To compare invasive breast cancer-free survival after surgery between
randomized arms in pCR and residual disease groups.

To compare the safety and tolerability by randomized arm among those that initiate
therapy.
Cancer Categories:
Breast
Principal Investigator:
Arjyal, Lubina
Karmanos Trial ID:
S2212
Age Group:
Adult
Phase:
Phase III
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A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Metastatic Prostate Cancer (SEACLIFF)
Objective:

Primary Objectives:

Dose Escalation (Part A)

To assess the safety and tolerability and to determine the MTD and/or RDE(s) of AZD0516 as monotherapy and in combination with anti-cancer agents.

Dose Optimisation (Part B)

To assess the preliminary antitumour activity of AZD0516 as monotherapy and in combination with anti-cancer agents.

To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents

Efficacy Expansion (Part C)

To assess the anti-tumour activity of AZD0516 as monotherapy and/or in combination with other anti-cancer agents.

Secondary Objectives:

Dose Escalation (Part A)

To assess the preliminary anti-tumour activity of AZD0516 as monotherapy and/or in combination with other anti-cancer agents.

Dose Escalation (Part A) and Dose Optimisation (Part B)

To characterise the PK of AZD0516 when given as monotherapy and in combination with anti-cancer agents.

To investigate STEAP2 expression and relationship to response to AZD0516.

To determine the immunogenicity of AZD0516 as monotherapy and in combination with anti-cancer agents.

Efficacy Expansion (Part C)

To further assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.
Cancer Categories:
Genitourinary (GU)
Principal Investigator:
Cackowski, Frank
Karmanos Trial ID:
2025-065
Age Group:
Adult
Phase:
Phase I/II
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A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) with Homozygous MTAP Deletion After Progression on Prior Therapies
Objective:

Part 1: Dose Selection

Primary Objective:

To evaluate investigator-assessed objective response (OR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

Secondary Objectives:

To evaluate investigator-assessed disease control (DC) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed clinical benefit (CB) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed duration of response (DOR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed progression-free survival (PFS) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed time to objective response (TTOR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To assess the safety and tolerability of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

Part 2 + Selected Dose from Part 1

Primary Objective:

To evaluate OR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

Secondary Objectives:

To evaluate investigator-assessed OR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate DC of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed DC of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate CB of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed CB of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate PFS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed PFS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate TTOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed TTOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate DOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed DOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To assess OS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To assess the safety and tolerability of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To assess the impact of disease symptoms and treatment on participant’s healthrelated quality-of-life in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
Cancer Categories:
Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2025-053
Age Group:
Adult
Phase:
Phase II
Learn More

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