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 186

  • 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:
    • Shao, Yusra
    Karmanos Trial ID:
    • S2200
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Dual Primary Objectives:

    • To compare progression-free survival (PFS) in frail or selected intermediate fit
      Newly Diagnosed Multiple Myeloma (NDMM) participants treated with VRd-Lite
      induction followed by Lenalidomide maintenance (Arm 1) versus DRd induction
      followed by Lenalidomide maintenance (Arm 2).
    • To compare overall survival (OS) in frail or selected intermediate fit NDMM
      participants treated with VRd-Lite induction followed by lenalidomide maintenance
      (Arm 1) versus DRd induction followed by lenalidomide and daratumumab and
      hyaluronidase-fihj maintenance (Arm 3).

    Secondary Objectives

    • To compare PFS in Arm 1 versus Arm 3
    • To compare OS in Arm 1 versus Arm 2.
    • To compare OS in Arm 2 versus Arm 3, contingent upon significant results from both dual primary endpoints in favor of the respective experimental arms.
    • To compare the overall response rate (ORR) of Arm 1 against the ORR of Arm 2 and Arm 3.
    • To assess the safety of Arm 1 with the safety of Arm 2 and Arm 3.
    • To explore veinous and arterial thrombo-embolism (VTE) incidence in participants receiving lenalidomide during induction across the three study arms.
    • To describe median time to response (CR or better per IMWG criteria, VGPR or better per IMWG criteria, PR or better per IMWG criteria) on the three study arms.
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Cole, Craig
    Karmanos Trial ID:
    • S2209
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objective:

    • To compare major organ deterioration progression-free survival between participants randomized to the ASCT and non-ASCT arms of this study.

    Secondary Objectives

    • To compare overall survival (OS) between participants randomized to the ASCT and non-ASCT arms of this study.
    • To compare rates of cardiac and renal organ responses between participants randomized to the ASCT and non-ASCT arms of this study.
    • To compare rates of cardiac and renal organ progression between participants randomized to the ASCT and non-ASCT arms of the study.
    • To compare the frequency and severity of toxicities between participants randomized to the ASCT and non-ASCT arms of this study.
    • To compare minimal residual disease (MRD) negativity rates between participants randomized to the ASCT and non-ACST arms of this study.
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Kin, Andrew
    Karmanos Trial ID:
    • S2213
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objectives:

    • To compare the progression-free survival in participants with relapsed/refractory
      large B-cell lymphoma or follicular lymphoma grade 3B with stable disease (SD)
      or partial remission (PR) on first imaging response by central review (day +30
      PET/CT scan) after commercial CD19 CAR T-cell therapy who are randomized to
      receive each consolidation therapy versus those that receive no consolidation
      therapy (i.e. control). Specifically, to compare the PFS of 1) mosunetuzumab
      consolidation to no consolidation, 2) polatuzumab vedotin consolidation to no
      consolidation, 3) mosunetuzumab + polatuzumab vedotin to no consolidation

    Secondary Objectives:

    • To compare overall survival (OS) in participants randomized to each consolidation
      treatment arm versus control.
    • To compare the complete remission (CR) conversion rate up to one year in
      participants randomized to each consolidation arm versus control.
    • To evaluate the treatment-related adverse events in participants randomized to
      each consolidation arm.
    • To evaluate the association between total metabolic tumor volume (TMTV), SUV
      max, and sum product (SPD) of diameters by PET-CT at first imaging response
      with complete remission conversion up to one year in participants randomized to
      each consolidation arm as well as those randomized to control.
    • To evaluate the overall response rate (ORR), CR rate, PFS, and OS of participants
      randomized to Arm 4 (observation) who have lymphoma progression within 12
      months of CAR T-cell infusion and subsequently ‘cross-over' to receive treatment
      with mosunetuzumab + polatuzumab vedotin.
    • To estimate overall survival for all patients registered to this study.
    • To assess the difference in overall survival between participants who achieved CR
      at first imaging (day +30) versus. those who did not achieve CR at first imaging.
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Uberti, Joseph
    Karmanos Trial ID:
    • S2114
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Objectives:

    • To compare the overall survival in patients with stage II-IIIC inoperable nodepositive
      non-small cell lung cancer (NSCLC) after image guided, motion-managed
      conventional radiotherapy to the primary tumor and nodal metastases (Arm 1) or after
      image guided, motion-managed stereotactic body radiation therapy (SBRT) to the
      primary tumor followed by conventionally fractionated radiotherapy to nodal
      metastases (Arm 2) both given with concurrent platinum-based chemotherapy.
    • To compare progression-free survival between the experimental arm (Arm 2) and
      control arm (Arm 1).

    Secondary Objectives:

    • To compare objective response rate (as defined by RECIST v 1.1) between the
      experimental arm and control arm
    • To compare the rate of local control between the experimental arm and control arm
    • To compare patterns of failure (primary, locoregional, or distant) between the
      experimental arm and control arm
    • To compare changes in pulmonary function (FEV1 and DLCO assessed at
      randomization and at 6 and 12 months following completion of radiation therapy)
      between the experimental arm and control arm
    • To compare changes in quality of life and patient-reported outcomes assessed from
      pre-treatment to 3 months following radiation therapy of each treatment arm
    • To determine acute and late toxicity profiles of each treatment arm as measured by
      the CTCAEv5
    Cancer Categories:
    • Lung
    Principal Investigator:
    • Yeh, Brian
    Karmanos Trial ID:
    • NRG-LU008
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objective:

    • To compare breast cancer event-free survival between participants randomized to standard of care neoadjuvant chemotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab.

    Secondary Objectives:

    • To compare pathologic complete response rates (ypT0/is, ypN0) in participants randomized to standard of care chemotherapy alone vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab
    • To compare residual cancer burden distribution between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab
    • To compare distant relapse-free survival between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab
    • To compare overall survival between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab
    • To compare the frequency and severity of toxicities between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab among those who initiate the assigned treatment.
    Cancer Categories:
    • Breast
    Principal Investigator:
    • Elayoubi, Jailan
    Karmanos Trial ID:
    • S2206
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objective

    Phase II:

    • To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone

    Phase III:

    • To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone

    Secondary Objectives

    • To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm
    • To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and >3 visible tumors
    • To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease (“complete consolidation”) and patients who do not receive consolidation radiation to all visible disease (“incomplete consolidation”)
    Cancer Categories:
    • Lung
    Principal Investigator:
    • Yeh, Brian
    Karmanos Trial ID:
    • NRG-LU007
    Age Group:
    • Adult
    Phase:
    • Phase II/III
  • Objective:

    Primary Objectives

    Among patients with metastatic extrapulmonary poorly differentiated small cell NEC, to compare overall survival (OS, measured from randomization) in a fixed sequence as follows:

    • Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3)
    • Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3)
    • Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2)

    Secondary Objective(s)

    • To compare OS, measured from start of observation/maintenance, across arms
    • To compare progression-free survival (PFS) (measured from randomization and measured from start of observation/maintenance) across arms
    • To compare objective response rate (ORR = confirmed and unconfirmed partial response (PR) + confirmed and unconfirmed complete response (CR)) across arms among patients with measurable disease at randomization
    • To compare clinical benefit rate (CBR = confirmed and unconfirmed PR + confirmed and unconfirmed CR + stable disease (SD)) across arms among patients with measurable disease at randomization
    • To compare the duration of response (DOR) across arms
    • To evaluate the safety and tolerability of each arm

    Additional Objective

    • To bank tumor and blood samples for future biomarker correlative studies
    Cancer Categories:
    • Gastrointestinal (GI)
    Principal Investigator:
    • Al Hallak, Mohammed
    Karmanos Trial ID:
    • S2012
    Age Group:
    • Adult
    Phase:
    • Phase II/III
  • Objective:

    Co-Primary Objectives:

    • To compare the 3-year milestone progression free survival (PFS) probabilities in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm.
    • To compare progression free survival (PFS) in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm.

    Secondary Objectives:

    • To compare overall survival (OS) between participants randomized to rituximab versus mosunetuzumab.
    • To compare overall response rates at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab.
    • To compare event free survival (EFS) between participants randomized to rituximab versus mosunetuzumab.
    • To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab.
    • To compare the restricted chance of longer PFS (2-6 years) between participants randomized to rituximab versus mosunetuzumab.
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Modi, Dipenkumar
    Karmanos Trial ID:
    • S2308
    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:
    • N/A