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.

Results 1 - 10 of 43

  • 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
  • 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
  • Objective:
    Primary Objective:
    • To examine if letrozole monotherapy/maintenance is non-inferior to IV paclitaxel/carboplatin and maintenance letrozole with respect to PFS in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction.
    Secondary Objectives:
    • To compare the nature, frequency and maximum degree of toxicity as assessed by CTCAE v5.0 for each treatment arm.
    • To compare the relative frequency of objective tumor response in those with measurable disease after cytoreductive surgery for each treatment arm.
    • To compare overall survival for each treatment arm.
    • To compare the CT\L and L\L arms with respect to patients adherence to letrozole therapy as measured by pill counts.
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Morris, Robert
    Karmanos Trial ID:
    • NRG-GY019
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Part 1

    Primary Objectives:

    • To characterize the safety and tolerability of TEV-56278 in the trial population
    • To determine a RP2D

    Secondary Objectives:

    • To characterize the serum pharmacokinetics of TEV-56278 in the trial population
    • To evaluate the antitumor activity of TEV-56278 in the trial population

    Part 2

    Primary Objectives:

    • To evaluate antitumor activity of TEV-56278 in the trial population

    Secondary Objectives:

    • To characterize the serum pharmacokinetics of TEV-56278 in the trial population
    • To determine the safety and tolerability of TEV-56278 in the trial population
    • To evaluate other measures of antitumor activity of TEV-56278 in the trial population
    Cancer Categories:
    • Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2024-045
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Phase 1a Dose Escalation

    Primary Objectives:

    • To assess the safety and tolerability of BGB-43395 alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.
    • To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended dose(s) for expansion (RDFE[s]) of BGB-43395 alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.

    Secondary Objectives:

    • To assess the preliminary anticancer activity of BGB-43395 alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.
    • To characterize the PK of BGB-43395 and its metabolite, BGB-48579, alone in patients with advanced solid tumors or as part of combination therapies in HR+/HER2- breast cancer and other selected tumor types.

    Phase 1b: Dose Expansion Objectives and Endpoints

    Primary Objectives:

    • To assess the antitumor activity in patients treated with BGB-43395 alone or as part of combination therapies in selected tumor cohorts.

    Secondary Objectives:

    • To further assess the antitumor activity in patients treated with BGB-43395 alone or as part of combination therapies in selected tumor cohorts.
    • To further characterize the safety and tolerability of BGB-43395 alone or as part of combination therapies.
    • To further characterize the pharmacokinetics (PK) of BGB-43395 and its metabolite, BGB-48579, with combination therapies.
    Cancer Categories:
    • Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2024-063
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objective:

    • To compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib vs Investigator’s Choice of Treatment (ICT) in patients with recurrent LGSOC

    Secondary Objectives:

    • To compare the combination of avutometinib plus defactinib vs ICT in patients with recurrent LGSOC with regard to additional efficacy parameters
    • To characterize the safety and tolerability of combination avutometinib plus defactinib vs ICT in patients with recurrent LGSOC
    • To determine the exposure of avutometinib and defactinib in patients with recurrent LGSOC treated with combination of avutometinib plus defactinib
    • To assess the health-related quality of life and disease related symptoms in patients with recurrent LGSOC treated with combination avutometinib plus defactinib vs ICT
    Cancer Categories:
    • Gastrointestinal (GI),Gynecologic
    Principal Investigator:
    • Morris, Robert
    Karmanos Trial ID:
    • GOG-3097
    Age Group:
    • Adult
    Phase:
    • Phase III
  • 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
  • Objective:

    Primary Objective:

    • To evaluate the safety and tolerability of GSK5733584 administered intravenously in subjects with advanced solid tumors to establish MTD or maximum applicable dose (MAD).

    Secondary objectives:

    • To evaluate the PK profile of GSK5733584 administered intravenously in subjects with advanced solid tumors.
    • To evaluate the clinical activity of GSK5733584 administered intravenously in subjects with advanced solid tumors.
    • To evaluate the immunogenicity of GSK5733584 administered intravenously in subjects with advanced solid tumors.
    • To further evaluate the safety and tolerability of GSK5733584 administered intravenously in subjects with advanced solid tumors
    Cancer Categories:
    • Breast,Gynecologic
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2024-053
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Phase 1a dose escalation

    Primary Objectives:

    • To determine the MTD/MAD and evaluate the safety and tolerability of GSK5764227 in participants with advanced solid tumors.

    Secondary Objectives:

    • To evaluate the PK profile of GSK5764227 in participants with advanced solid tumors.
    • To evaluate the clinical activity of GSK5764227 in participants with advanced solid tumors
    • To evaluate the immunogenicity of GSK5764227 in participants with advanced solid tumors.To evaluate the immunogenicity of GSK5764227 in participants with advanced solid tumors.

    Phase 1b dose expansion

    Primary Objectives:

    • To evaluate the clinical activity of GSK5764227 in participants with ES-SCLC or advanced solid tumors.

    Secondary Objectives:

    • To evaluate the safety and tolerability of GSK5764227 in participants with ES-SCLC or advanced solid tumors
    • To evaluate additional measures of clinical benefit of GSK5764227 in participants with ES-SCLC or advanced solid tumors.
    • To evaluate the PK profile of GSK5764227 in participants with ES-SCLC or advanced solid tumors.
    • To evaluate the immunogenicity of GSK5764227 in participants with ES-SCLC or advanced solid tumors.
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung,Skin
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2024-073
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objective:

    • The primary objective is to determine Progression-free Survival (PFS) by RECIST 1.1.

    Key Secondary Objectives:

    • To determine Objective Response Rate (ORR) and Duration of Response (DOR) by RECIST 1.1, PFS by RECIST 1.1 (in modified population), PFS by iRECIST, Overall Survival (OS), and safety.

    Key Other Objectives:

    • To determine ORR by the Gynecological Cancer Intergroup (GCIG) CA-125 criteria, and Clinical Benefit Rate [CBR = (CR + PR + SD ≥ 15 weeks)/total # of patients evaluated by RECIST 1.1 or iRECIST]. Additional analyses of efficacy endpoints in modified population are included.
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Morris, Robert
    Karmanos Trial ID:
    • GOG-3076
    Age Group:
    • Adult
    Phase:
    • Phase III