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 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:

    • 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.
    • 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.
    • 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).
    • 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)
    • 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:

    • 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:

    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 Objectives:

    • To compare pembrolizumab to chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR
    • Hypothesis (H1): Pembrolizumab is superior to chemotherapy with respect to PFS per RECIST 1.1 by BICR
    • To compare pembrolizumab to chemotherapy with respect to OS
    • Hypothesis (H2): Pembrolizumab is superior to chemotherapy with respect to OS

    Secondary Objectives:

    • To compare pembrolizumab to chemotherapy with respect to ORR per RECIST 1.1 by BICR in participants with measurable disease at study entry
    • Hypothesis (H3): Pembrolizumab is superior to chemotherapy with respect to ORR per RECIST 1.1 by BICR in participants with measurable disease at study entry
    • To compare pembrolizumab to chemotherapy with respect to DCR per RECIST 1.1 by BICR in participants with measurable disease at study entry
    • To compare pembrolizumab to chemotherapy with respect to DOR per RECIST 1.1 by BICR in participants with measurable disease at study entry
    • To compare pembrolizumab to chemotherapy with respect to PFS as per RECIST 1.1 assessed by the investigator
    • To compare pembrolizumab to chemotherapy with respect to PFS2 as assessed by the investigator
    • To compare the safety and tolerability of pembrolizumab to chemotherapy
    • To compare pembrolizumab to chemotherapy with respect to change from baseline score and TTD in the EORTC QLQ-C30 GHS/QoL
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Gogoi, Radhika
    Karmanos Trial ID:
    • GOG-3064
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objective:

    • 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:

    • Efficacy: To assess the antitumor activity of XmAb20717

    Secondary Objectives:

    • PK: To characterize the PK of XmAb20717
    • Safety: To determine the safety and tolerability profile of XmAb20717

    Exploratory Objectives:

    • Patient Stratification/Predictive: To establish potential biomarkers associated with clinical response in baseline biopsies and blood
    • Pharmacodynamics: To explore pharmacodynamic effects of XmAb20717 in blood and in baseline and optional on treatment tumor biopsies
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2022-034
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Objectives:

    • Determine the maximum tolerated dose (MTD) of CB-03-10 in subjects with advanced solid tumors
    • Determine the dose-limiting toxicity (DLT) of CB-03-10 in subjects with advanced solid tumors

    Secondary Objectives:

    • Determine a recommended Phase 2 dose (RP2D) of CB-03-10
    • Determine the safety profile of CB-03-10 in subjects with advanced solid tumors
    • Evaluate the activity (response rate, PFS, and OS) of CB-03-10 in subjects with specific solid tumors (e.g., relapsed/refractory pancreatic adenocarcinoma, androgen independent prostate adenocarcinoma, relapsed/refractory triple-negative breast adenocarcinoma)
    • Characterize the pharmacokinetics (PK) of CB-03-10 and its metabolite CB-03-05 as well as cortexolone in plasma and urine.
    Cancer Categories:
    • Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Other,Sarcoma,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2022-036
    Age Group:
    • Adult
    Phase:
    • Phase I
  • 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:

    • To evaluate the safety and tolerability of SGN1 in patients with advanced solid tumor.

    Secondary Objectives:

    • To make a preliminary determination of the Maximum Tolerated Dose (MTD) and optimal biological dose (OBD).
    • To evaluate blood and urine levels of SGN1.
    • To evaluate bacterial shedding of SGN1.
    • To evaluate the anti-tumor effect of SGN1 in the treatment of patients with advanced solid tumor.
    • To evaluate additional safety measures.
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Uprety, Dipesh
    Karmanos Trial ID:
    • 2021-073
    Age Group:
    • Adult
    Phase:
    • Phase I