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 179

  • 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
  • Objective:

    Primary Objective:

    • To determine if ado-trastuzumab emtansine (T-DM1) shows better progression-free survival (PFS) when compared to docetaxel plus trastuzumab (TH) in recurrent and/or metastatic (R/M) HER2-positive salivary gland cancer (SGC) patients who have not previously received HER2 therapy for unresectable or recurrent and/or metastatic disease, as determined by local assessment.

    Secondary Objectives:

    • To compare the overall response rate (ORR) by RECIST v1.1 criteria between arms;
    • To compare overall survival (OS) between arms;
    • To compare toxicity using CTCAE v5.0 criteria between arms;
    • To assess patient-reported toxicity, as measured by the PRO-CTCAE, between arms, and explore patient-reported symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the PRO-CTCAE.
    Cancer Categories:
    • Head and Neck
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • NRG-HN010
    Age Group:
    • Adult
    Phase:
    • Phase II
  • 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 investigate the safety of monotherapy and T- Plex combination TCR-Ts
    • To determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

    Secondary Objectives:

    • To investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts
    • To investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts
    Cancer Categories:
    • Gynecologic,Hematologic (Blood Cancers),Lung,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2023-086
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    BGB-16673 Monotherapy Dose Finding (Phase 1)

    Primary Objectives:

    • To evaluate the safety and tolerability of BGB-16673 monotherapy
    • To define the maximum tolerated dose (or maximum assessed dose) and the
      recommended Phase 2 dose (RP2D) of BGB-16673

    Secondary Objectives:

    • To characterize the pharmacokinetic profile of BGB-16673 as monotherapy
    • To characterize the pharmacodynamic profile of BGB-16673 in peripheral blood
    • To characterize the preliminary antitumor activity of BGB-16673 monotherapy

    BGB-16673 Monotherapy (Phase 2)

    Primary Objectives:

    • To evaluate the antitumor activity of BGB-16673 monotherapy in patients with
      relapsed/refractory (R/R) mantle cell lymphoma (MCL) based on overall response
      rate (ORR) as assessed by an Independent Review Committee (IRC)
    • To evaluate the antitumor activity of BGB-16673 monotherapy in patients with R/R
      CLL/SLL based on ORR as assessed by investigators

    Secondary Objectives:

    • To evaluate the safety and tolerability of BGB-16673 monotherapy
    • To further characterize the pharmacokinetic profile of BGB-16673
    • To further characterize the pharmacodynamic profile of BGB-16673 in peripheral
      blood
    • Patients with R/R MCL:
      • To evaluate the antitumor activity of BGB-16673 monotherapy based on ORR as
        assessed by investigators
      • To evaluate the antitumor activity of BGB-16673 monotherapy based on best
        overall response (BOR), time to response (TTR), duration of response (DOR), and
        progression-free survival (PFS) as assessed by the IRC and investigators
      • To characterize overall survival
      • To measure patient-reported outcomes (PRO) in R/R MCL patients via National
        Comprehensive Cancer Network Functional Assessment of Cancer Therapy –
        Lymphoma System Index-18 (NFLymSI-18)
    • Patients with R/R CLL/SLL:
      • To evaluate the antitumor activity of BGB-16673 monotherapy based on ORR,
        DOR, TTR, and PFS as assessed by investigators
      • To characterize overall survival
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Modi, Dipenkumar
    Karmanos Trial ID:
    • 2023-094
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Phase 1 Dose Escalation

    Primary Objectives:

    • To evaluate the safety and tolerability of CA-4948 in patients with R/R AML and
      hrMDS
    • To identify the MTD and RP2D

    Secondary Objectives:

    • To characterize the PK parameters of CA-4948 using non-compartmental analysis
      and appropriate PK modelling
    • To assess anti-cancer activity

    Phase 2a Dose Expansion

    Primary Objective:

    • To assess anti-cancer activity of CA-4948 at RP2D in patients with R/R AML with
      FLT-3 mutations, and patients with R/R hrMDS or R/R AML with spliceosome
      mutations of SF3B1 or U2AF1

    Secondary Objectives:

    • To assess tolerability and long-term safety
    • To further assess anti-cancer activity of CA-4948 at RP2D
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Yang, Jay
    Karmanos Trial ID:
    • 2023-095
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objective:

    • To evaluate the antitumor activity of nemvaleukin alfa (‘nemvaleukin’, ALKS 4230)in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancer

    Secondary Objectives:

    • To evaluate the antitumor activity of nemvaleukin in combination with pembrolizumab as compared with chemotherapy
    • To evaluate the safety of nemvaleukin in combination with pembrolizumab as compared with chemotherapy
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Morris, Robert
    Karmanos Trial ID:
    • GOG-3063
    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(s):

    • To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib with atezolizumab versus cabozantinib alone.
       

    Secondary Objective(s):

    • To compare overall survival in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
    • To compare RECIST objective response rate (confirmed and unconfirmed, complete and partial response) in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
    • To evaluate the quantitative & qualitive adverse events observed in each treatment arm.
    Cancer Categories:
    • Genitourinary (GU)
    Principal Investigator:
    • Heath, Elisabeth
    Karmanos Trial ID:
    • S2200
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Objectives:

    • Phase II: To assess the efficacy of concurrent definitive therapy followed by nivolumab compared with concurrent definitive therapy followed by observation in terms of progression-free survival (PFS).
    • Phase III: To assess the efficacy of concurrent definitive therapy followed by nivolumab compared with concurrent definitive therapy followed by observation in terms of overall survival (OS).

    Secondary Objectives:

    • To further assess the efficacy of nivolumab compared with observation in terms of the relationship of baseline PD-L1 expression to clinical outcome.
    • To evaluate the predictive value of HPV16 E6 and E7 DNA in saliva and plasma, at baseline, 12 weeks and 9 months after completion of radiation on PFS and OS in both arms of the study.
    • To evaluate the tumor mutation burden by whole exome sequencing of the initial pretreatment tissue sample as well as samples obtained at the time of progression.
    • To evaluate the association of 12 week post therapy FDG PET/CT with PFS and OS.
    • To establish the prognostic value of SUVmax of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS (and/or PFS).
    • To correlate SUVmax of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive vs. negative).
    • To correlate the post therapy (cisplatin + RT) FDG PET/CT with saliva or plasma levels of HPV DNA collected at the time of the standard 3 months PET/CT scan as well as 6 months later (i.e. 9 months post therapy) for both the observation and Nivolumab groups.
    • To compare the PET based therapy response assessment (Hopkins criteria) to the RECIST 1.1 assessment at 12 week post chemoradiation therapy, for patients who have a PET/CT scan at 12 weeks.
    Cancer Categories:
    • Head and Neck
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • EA3161
    Age Group:
    • Adult
    Phase:
    • Phase II/III