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 30

  • 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:
    • NA
  • Objective:

    Primary Objectives:

    • To compare the 3-year recurrence-free survival of women with high intermediate risk (HIR) Stage I/II mismatch repair deficient (dMMR) endometrioid endometrial cancer treated with radiation and MK-3475 (pembrolizumab) versus radiation alone.

    Secondary Objectives:

    • To describe the safety and tolerability of concurrent MK-3475 (pembrolizumab) and radiation compared to radiation alone in patients with MMR deficient high intermediate risk endometrial cancer (HIR EC).
    • To describe the recurrence patterns in each group.
    • To measure recurrence free survival at 5 years in each group.
    • To estimate disease specific overall survival in each group.
    • To determine whether the addition of MK-3475 (pembrolizumab) to radiation, compared with radiation alone is associated with decreased quality of life at 6- and 24-weeks, as measured with the FACT-En TOI, increased GI symptoms as measured with the GI subscale, and increased fatigue as measured with the PROMIS-Fatigue scale (short form).
    • To validate the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) subscale, which assesses in cancer patients on immunotherapy.
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Gogoi, Radhika
    Karmanos Trial ID:
    • NRG-GY020
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:
    Primary Objective
    • To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single agent cediranib as measured by progression free survival (PFS), in patients with recurrent, persistent or metastatic endometrial cancer.
    Secondary Objectives
    • 1.2.1 To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single-agent cediranib as measured by overall survival (OS) in patients with recurrent, persistent or metastatic endometrial cancer.
    • 1.2.2 To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment versus single-agent cediranib as measured by response rate in patients with recurrent, persistent or metastatic endometrial cancer.
    • 1.2.3 To assess the safety and tolerability of single–agent cediranib, single-agent olaparib, and the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment).
    • 1. 2.4 To assess if mutations in DNA Homologous Repair Genes (assayed prior to all treatment and prior to the study treatment) are predictive of response to olaparib alone or in combination with cediranib. (Integrated Biomarker)
    • 1.2.5 To assess if markers of angiogenesis in serial plasma samples are associated with response to cediranib alone or in combination with olaparib. (Integrated Biomarker)
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Gogoi, Radhika
    Karmanos Trial ID:
    • NRG-GY012
    Age Group:
    • Adult
    Phase:
    • Phase II
  • 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:
    Primary Objective
    • Evaluate the success of targeting a carboplatin AUC with our current approach to dosing carboplatin.
    • Assess the performance of CG, MDRD-4, and CKPD-EPI based on IDMS calibrated serum creatinine in predicting mGFR in patients with cancer.
    • Define the relationship of mGFR and carboplatin clearance in patients with cancer.
    Secondary Objectives
    • Evaluate the divergence of eGFR from mGFR based on patient demographic and other characteristics, thus identifying those most likely to benefit from determination of mGFR over use of eGFR.
    • Determine the success rate of achieving the target carboplatin AUC in patients in whom the carboplatin dose is capped.
    • Evaluate the relationship between carboplatin exposure and toxicity.
    • Assess the ability of markers other than creatinine in pretreatment serum to better estimate kidney function in patients with cancer.
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • NRG-GY022
    Age Group:
    • Adult
    Phase:
    • NA
  • Objective:

    Objectives (UPLIFT):

    Primary in Pivotal Cohort (UPLIFT):

    • Determine the confirmed investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) in patients with higher sodium-dependent phosphate transport protein 2b (NaPi2b) expressing platinum-resistant high-grade serous ovarian cancer (HGSOC), including cancers of ovarian, fallopian tube or primary peritoneal origin)

    Secondary in UPLIFT:

    • Assess the investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression.
    • Assess the objective response rate by independent radiology review (IRR) for patients with higher NaPi2b and overall.
    • Assess the duration of objective response (DOR) in patients who achieve a response.
    • Assess the incidence and severity of adverse events (AEs).

    Exploratory in DES, EXP and UPLIFT:

    • Retrospectively evaluate the association of objective response with tumor expression of genes other than NaPi2b, or other tumor molecular and histologic features

    Exploratory in UPLIFT:

    • Assess the disease control rate (DCR)
    • Assess the progression-free survival (PFS)
    • Assess the overall survival (OS)
    • Assess the population PK
    • Assess the relationship of XMT-1536 (upifitamab rilsodotin) exposure to efficacy and safety outcomes.
    • Assess development of anti-drug antibody and neutralizing antibody in response to XMT-1536 (upifitamab rilsodotin) exposure
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • GOG-3048
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:
    Primary
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review or by histopathologic confirmation of suspected local disease progression (in the absence of radiographic disease progression per RECIST 1.1)
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to overall survival
    Secondary
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to progression-free survival at 2 years per RECIST 1.1 as assessed by blinded independent central review or by histopathologic confirmation of suspected local disease progression (in the absence of radiographic disease progression per RECIST 1.1)
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to overall survival at 3 years
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to complete response rate at 12 weeks after concurrent chemoradiotherapy per RECIST 1.1 as assessed by blinded independent central review in all randomly assigned participants with measurable disease at study entry
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to objective response rate per RECIST 1.1 as assessed by blinded independent central review in all randomly assigned participants with measurable disease at study entry
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to overall survival and progression-free survival per RECIST 1.1 as assessed by blinded independent central review or by histopathologic confirmation of suspected local disease progression (in the absence of radiographic disease progression per RECIST 1.1), by PD-L1 status (by combined positivity score)
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to progression-free survival after next-line treatment (progression-free survival 2) following discontinuation of study treatment administration as determined by the investigator according to the local standard of clinical practice
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to change from baseline score in global quality of life and physical function using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) global health status/Quality of Life scale and Physical Function subscale
    • To compare concurrent chemoradiotherapy plus pembrolizumab with concurrent chemoradiotherapy plus placebo with respect to change from baseline score in symptom experience using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (Symptom Score for Cervical Cancer) the EORTC CX24 symptom specific scale (11 items)
    • To evaluate the safety and tolerability of pembrolizumab in combination with concurrent chemoradiotherapy
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Wallbillich, John
    Karmanos Trial ID:
    • GOG-3047
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:
    Primary Objectives:
    • To evaluate antitumor activity of INCMGA00012 in Group A.

    Secondary Objectives:
    • To further evaluate clinical efficacy of INCMGA00012 monotherapy and evaluate clinical activity in the combinations.
    • To evaluate the safety and tolerability of INCMGA00012 as monotherapy and in combination.
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Gogoi, Radhika
    Karmanos Trial ID:
    • GOG-3038
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Objectives:

    Phase 1

    • Assess safety and tolerability of NUV-868 as monotherapy and determine the recommended phase 2 dose (RP2D) for monotherapy treatment

    Phase 1b

    • Assess safety and tolerability of NUV-868 as combination therapy and determine the recommended phase 2 combination dose (RP2cD) for each combination treatment
    • Evaluate the potential drug interaction between NUV-868 and olaparib
    • Evaluate the potential drug interaction between NUV-868 and enzalutamide

    Phase 2

    • Evaluate efficacy of NUV-868 as monotherapy

    Phase 2b

    • Evaluate efficacy of NUV-868 as combination therapy

    Secondary Objectives:

    Phase 1

    • Explore preliminary efficacy of NUV-868 as monotherapy
    • Characterize the PK profile of NUV-868
    • Characterize the effect of food on the PK profile of NUV-868

    Phase 1b

    • Explore preliminary efficacy of NUV-868 as combination treatment

    Phase 2

    • Further evaluate efficacy of NUV-868 as monotherapy

    Phase 2b

    • Further evaluate efficacy of NUV-868 as combination therapy

    Phase 2 and Phase 2b

    • Evaluate drug exposure response relationship

    Phase 1, 1b, 2 and Phase 2b

    • Further evaluate safety
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic
    Principal Investigator:
    • Shields, Anthony
    Karmanos Trial ID:
    • 2022-026
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objectives:

    The primary objectives of the escalation (Parts A-1 and A-2) are:

    • To assess safety and tolerability of BT5528 in patients with advanced solid tumor malignancies associated with EphA2 expression and/or tumors identified as positive for EphA2 tumor expression as a monotherapy (Part A-1) and in combination with nivolumab (Part A-2)
    • To define the maximum tolerated dose (MTD) of BT5528, if observed, and determine a recommended Phase II dose (RP2D) as a monotherapy (Part A-1) and in combination with nivolumab (Part A2).

    The primary objective of the expansion (Part B) is:

    • To assess the clinical activity of BT5528 as monotherapy in patients with solid tumors historically known for high expression of EphA2 (Cohort B-1: urothelial cancer, Cohort B-2: ovarian cancer, Cohort B-3: non-small cell lung cancer [NSCLC], Cohort B-4: head and neck cancer, Cohort B-5: triple negative breast cancer (TNBC), and Cohort B-6: gastric/upper gastrointestinal cancer [GI])

    Secondary Objectives:

    The secondary objectives of the escalation (Parts A-1 and A-2) of this study are:

    • To assess preliminary signals of anti-tumor activity achieved with BT5528 administration in patients with advanced solid tumor malignancies associated with EphA2-expression and/or specified tumors identified as positive for EphA2 tumor expression as a monotherapy (Parts A-1) and in combination with nivolumab (Parts A-2)
    • To determine pharmacokinetic (PK) parameters of BT5528 and MMAE (as appropriate)
    • To determine incidence of anti-drug antibody (ADA) development

    The secondary objectives of the expansion cohorts (Part B) are:

    • To assess safety and tolerability of BT5528 as monotherapy in patients with tumors historically known for high expression of EphA2
    • To investigate whether tumor EphA2 expression levels are predictive of clinical activity with BT5528 monotherapy in patients with tumors historically known for high expression of EphA2
    • To determine pharmacokinetic (PK) parameters of BT5528 and MMAE (as appropriate)
    • To determine incidence of anti-drug antibody (ADA) development
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung
    Principal Investigator:
    • Mamdani, Hirva
    Karmanos Trial ID:
    • 2021-069
    Age Group:
    • Adult
    Phase:
    • Phase I/II