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 169

  • 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:

    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 Objective:

    De-Intensification Study:

    • To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with RT alone instead of 6 months ADT + RT experience non-inferior rate of distant metastasis.

    Intensification Study:

    • To determine whether men with NCCN UIR prostate cancer who are in the higher genomic risk (Decipher score ≥0.40) will have a superior metastasis-free survival through treatment intensification with darolutamide added to the standard of RT plus 6 months ADT.

    Secondary Objectives:

    • To compare overall survival (OS) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
    • To compare time to PSA failure between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
    • To compare metastasis free survival (MFS) based on conventional imaging between the standard of care (RT plus 6 months of ADT) and de-intensification intervention (RT alone).
    • To compare MFS based on either conventional and/or molecular imaging between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
    • To compare cumulative incidence of locoregional failure based upon conventional imaging and/ or biopsy between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months ADT plus darolutamide) interventions.
    • To compare cumulative incidence of distant metastasis based upon conventional imaging between standard of care (RT plus 6 months of ADT) and intensification intervention (RT plus 6 months ADT plus darolutamide).
    • To compare cumulative incidence of distant metastasis based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
    • To compare prostate cancer-specific mortality between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
    • To compare sexual and hormonal related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
    • To compare fatigue, as measured by the PROMIS-Fatigue instrument, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
    • To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
    Cancer Categories:
    • Genitourinary (GU)
    Principal Investigator:
    • Yeh, Brian
    Karmanos Trial ID:
    • NRG-GU010
    Age Group:
    • Adult
    Phase:
    • Phase III
  • 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:

    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 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