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 181

A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Objective:

Part A

Primary Objective:

To compare the MMR rate at 24 weeks for olverembatinib versus bosutinib

Secondary Objectives:

To compare the MMR rate at 96 weeks for olverembatinib versus bosutinib

To compare additional parameters of the efficacy of olverembatinib versus bosutinib

To compare the safety profile of olverembatinib versus bosutinib

To characterize the Population PK of olverembatinib in the CML-CP population

To evaluate Patient-Reported Outcome (PRO) measures of olverembatinib

To evaluate Health Economics Outcomes Research (HEOR) measures of olverembatinib

Part B

Primary Objective:

To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation

Secondary Objectives:

To evaluate the MMR rate by 96 weeks of olverembatinib in CML-CP patients with T315I mutation

To compare additional parameters of the efficacy of olverembatinib in CML-CP patients with T315I mutation

To evaluate the safety profile of olverembatinib in CML-CP patients with T315I mutation

To characterize the population PK of olverembatinib in the CML-CP population with T315I mutation

To evaluate PRO measures of olverembatinib

To evaluate HEOR measures of olverembatinib
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Yang, Jay
Karmanos Trial ID:
2025-006
Age Group:
Adult
Phase:
Phase III
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A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophosectomy to Reduce the Risk of Ovarian Cancer among BRCA1 Carriers [SOROCk]
Objective:

Primary Objective:

To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germ-line mutations.

Secondary Objectives:

To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACTES sub-scale compared to women in the BSO arm.

To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients.

To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.

To assess adverse events, graded using CTCAE v5.0.
Cancer Categories:
Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
NRG-CC008
Age Group:
Adult
Phase:
N/A
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A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects with HER2 Expressing Advanced Malignant Solid Tumors
Objective:

Primary Objectives:

To assess the safety and tolerability of BL-M07D1 in metastatic or unresectable HER2-expressing tumors

To determine the MTD if reached or MAD and two or more RDEs of BL-M07D1

Secondary Objectives:

To characterize the pharmacokinetics of BL-M07D1, total anti-HER2 antibody, and payload (Ed-04)

To investigate the antitumor activity of BL-M07D1
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-010
Age Group:
Adult
Phase:
Phase I
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A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects with Non-Oncology Plasma Cell-Related Diseases
Objective:

Primary Objective:

The primary objective of this study is to assess the safety profile, including any DLT and identification of a MTD (if applicable), to support selection of the RP2D of anito-cel when administered to subjects with GMG.

Secondary Objectives:

To quantify the clinical effect of anito-cel using standard clinical assessments, including Quantitative Myasthenia Gravis (QMG), Myasthenia Gravis Quality of Life (MG QoL 15R), Myasthenia Gravis Activities of Daily Living (MG ADL), MG Composite (MGC), Myasthenia Gravis Foundation of America (MGFA) Class, and MG Post Intervention Status (MG PIS)

To determine the change from Baseline in the titer of myasthenia gravis-specific autoantibodies in all subjects following infusion of anito-cel

To evaluate the PK in subjects treated with anito-cel in peripheral blood by VCN

To characterize the treatment-free interval (period during which no non-steroidal therapy, including immunosuppressive therapy, is required) following cell infusion

To characterize the corticosteroid dose reduction following cell infusion

To determine the rate of disease related hospitalizations or treatment complications following treatment and descriptively compare to the rate of occurrence prior to treatment

To assess for the presence of RCL in subjects
Cancer Categories:
Brain and Nervous System,Sarcoma
Principal Investigator:
Uberti, Joseph
Karmanos Trial ID:
2025-012
Age Group:
Adult
Phase:
Phase I
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A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN00-3694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer
Objective:

Primary Objectives:

To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities
(DLTs) for combination of ATR inhibitor (M1774) and BET inhibitor (ZEN003694) in
women with recurrent clear cell, endometrioid, and platinum resistant high grade serous
ovarian carcinoma (HGSOC) and clear cell and endometrioid endometrial carcinoma
irrespective of ARID1A status (PART I).

To determine safety and tolerability in ARID1A pathogenic alteration (ARID1AMUT) and
ARID1A wildtype (ARID1AWT) cohorts (ARID1A is an integral biomarker) in an
expansion phase (PART II).

To determine change in pharmacodynamic biomarker expression of ƔH2AX (for ATR
inhibition, integral biomarker) from pre-treatment and on-treatment tumor samples in
ARID1AMUT and ARID1AWT expansion cohorts by immunohistochemistry (IHC) (PART
II).

Secondary Objectives:

To evaluate change in pharmacodynamic biomarker expression of cmyc (for BET inhibition,
integrated biomarker) from pre-treatment and on-treatment tumor samples in ARID1AMUT
and ARID1AWT expansion cohorts by Digital Spatial Profiling (DSP) (PART II).

To evaluate change in pharmacodynamic biomarker expression of ƔH2AX (for ATR
inhibition, integrated biomarker) from pre-treatment and on-treatment tumor samples in
ARID1AMUT and ARID1AWT expansion cohorts by DSP (PART II).

To investigate if ARID1A protein by IHC and DSP correlates with ARID1A pathogenic
alteration in pre-treatment tumor biopsy samples (PART II).

To estimate objective response rate (ORR) and progression free survival (PFS) at 6 months in
ARID1A pathogenic alteration and wildtype cohorts (PART II).
Cancer Categories:
Gastrointestinal (GI),Gynecologic
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
NRG-GY031
Age Group:
Adult
Phase:
Phase I
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A Phase 1b/2a, Multicenter, Open-Label Study of Pocenbrodib as Monotherapy and in Combination with Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Objective:

Primary Objectives:

Phase 1b:

Confirm the safety and tolerability of pocenbrodib monotherapy in men with mCRPC

Determine the RP2D of pocenbrodib as monotherapy in men with mCRPC

Phase 2a:

Evaluate the clinical activity of pocenbrodib in men with mCRPC as monotherapy and in combination with abiraterone acetate, olaparib, or lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617)

Secondary objectives:

Phase 1b and Phase 2a:

Characterize the PK of pocenbrodib in men with mCRPC

Evaluate the relationship between exposure to pocenbrodib and effect (response, safety, and/or resistance)
Principal Investigator:
Cackowski, Frank
Karmanos Trial ID:
2025-020
Age Group:
Adult
Phase:
Phase I/II
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A Phase 2, Safety and Efficacy Study of PRT3789 in Combination with Pembrolizumab in Patients with Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation
Objective:

Primary Objectives:

Part 1

To evaluate the safety and tolerability of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic solid tumors

Part 2

To evaluate the efficacy of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic esophageal or NSCLC and deleterious SMARCA4 mutation

Secondary Objectives:

To evaluate the efficacy of PRT3789 in combination with pembrolizumab

To evaluate the safety and tolerability of PRT3789 in combination with pembrolizumab

To evaluate the PK profile of PRT3789 in combination with pembrolizumab
Cancer Categories:
Gastrointestinal (GI),Gynecologic,Head and Neck,Lung,Skin
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2025-005
Age Group:
Adult
Phase:
Phase II
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A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs. Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Related Head and Neck Squamous Cell Carcinoma (HNSCC)
Objective:

Primary Objective:

The primary objective of the study is to compare OS between subjects who receive PDS0101 plus pembrolizumab (investigational arm) and those who receive pembrolizumab alone (control arm).

Secondary Efficacy Objectives

To compare objective response rate (ORR) between the investigational arm vs control arm

To compare disease control rate (DCR) between investigational arm vs control arm

To compare duration of response (DOR) between the investigational arm vs control arm

To compare progression free survival (PFS) between the investigational arm vs control arm
Cancer Categories:
Head and Neck
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
2025-016
Age Group:
Adult
Phase:
Phase III
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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
Learn More

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