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 187

  • 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:

    • To evaluate the feasibility of molecular characterization based on TMB for
      participant stratification, as assessed by the proportion of participants with less
      than or equal to a 21-day turnaround time for biopsy results in Stage I of the study.
    • To evaluate the feasibility of molecular characterization based on TMB and GEP
      (for TIS) for stratification in the overall study (Stage I and Stage II).
    • To evaluate the efficacy by overall response rate (ORR – defined as confirmed
      and unconfirmed partial responses plus complete responses) of cabozantinib plus
      nivolumab in each disease cohort, both across and within tumor biomarker
      subgroups.

    Secondary Objectives:

    • To assess the difference in ORR in each disease cohort between tumor marker
      subgroups separately for each disease cohort.
    • To assess safety and tolerability of this treatment in these populations.
    • To estimate disease control rate (DCR) in participants receiving cabozantinib plus
      nivolumab in each disease cohort, stratified by tumor biomarkers.
    • To estimate progression-free survival (PFS) in participants receiving cabozantinib
      plus nivolumab in each disease cohort, stratified by tumor biomarkers.
    • To estimate overall survival (OS) in participants receiving cabozantinib plus
      nivolumab in each disease cohort, stratified by tumor biomarkers.
    • To assess the proportion of patients with assay failure, and the time from the date
      of tissue collection to molecular group determination at the end of Stage I.
    • To assess turnaround time for TIS for at least 30 patients in Stage I to ensure that
      at least 75% have a turnaround time of <21 days. If TIS is not ready for real-time
      testing when 30 slots remain for Stage I, accrual will be paused until assay
      validation is complete
    Cancer Categories:
    • Head and Neck,Skin
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • S2101
    Age Group:
    • Adult
    Phase:
    • Phase II
  • 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
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    Cancer Categories:
    • Gastrointestinal (GI)
    Principal Investigator:
    • Al Hallak, Mohammed
    Karmanos Trial ID:
    • S2012
    Age Group:
    • Adult
    Phase:
    • Phase II/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 Objectives:

    • Phase II: Progression Free Survival
      To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Efficacy will be determined via investigator assessed progression free survival (PFS) as assessed by RECIST 1.1. The two experimental arms (Arms 2 and 3) will be compared to the reference arm (Arm 1). If the experimental arms demonstrate superiority to the reference, the experimental arms will be compared to each other.
    • Phase III: Overall Survival
      To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Efficacy will be determined via investigator assessed overall survival (OS). The two experimental arms (Arms 2 and 3) will be compared to the reference arm (Arm 1). If the experimental arms demonstrate superiority to the reference, the experimental arms will be compared to each other.

    Secondary Objectives:

    • To evaluate the overall response rate (ORR) in patients with measurable disease. The ORR will be defined as the binomial proportion of evaluable patients with a best overall response of CR or PR (by RECIST 1.1) within 12 months of initiating maintenance therapy.
    • To evaluate the duration of objective response in patients with measurable disease as assessed by RECIST 1.1.
    • To determine the nature, frequency and degree of toxicity as assessed by CTCAE v.5.0 for each treatment arm.
    • To compare QOL, as measured by FACT-En-TOI, in the experimental versus control arms.
    • To compare patient-reported treatment-associated symptoms (diarrhea and rash) as measured with the PRO -CTCAE, patient-reported fatigue as measured with the PROMIS-Fatigue short form, and worry concerning side effects of treatment as measured by the item ‘bothered by side effect’, in the FACT-En TOI, respectively, in the experimental and control arms.
    • To assess the correlation of HER2 IHC expression and ISH amplification with clinical outcome and response to HER2 targeted therapies.
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Gogoi, Radhika
    Karmanos Trial ID:
    • NRG-GY026
    Age Group:
    • Adult
    Phase:
    • Phase II/III
  • 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 overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients.
    Secondary Objectives of First Randomization:
    • To compare the best overall response rate (ORR), including partial remission (PR), very good partial remission (VGPR), and complete remission (CR, sCR) in the subset of patients not in PR at randomization to lenalidomide versus lenalidomide + daratumumab/rHuPH20 in this patient population.
    • To compare progression-free survival (PFS) between the study arms in this patient population.
    • To evaluate MRD-negativity on the two treatment arms at randomization (Registration Step 2), and to compare MRD-negativity rate at 12, 24 (second randomization), 36, and 48 months after first randomization between lenalidomide and lenalidomide + daratumumab/rHuPH20 in this patient population.
    • To compare toxicities and tolerability of long term therapy between the study arms.
    Objectives of Second Randomization:
    • To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide vs. discontinued lenalidomide from the time of second randomization in this patient population.
    • To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide + daratumumab/rHuPH20 vs. discontinued lenalidomide + daratumumab/rHuPH20 from time of second randomization in this patient population.
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Kin, Andrew
    Karmanos Trial ID:
    • S1803
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objective:

    • To evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.

    Secondary Objectives:

    • To evaluate the safety and tolerability associated with the combination of olaparib + pembrolizumab vs. olaparib alone as maintenance therapy.
    • To evaluate the overall survival (OS) of patients treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.
    • To evaluate the overall response rate (ORR) by RECIST 1.1, including confirmed and unconfirmed, complete and partial response, of patients treated with olaparib + pembrolizumab compared to olaparib alone, in the subset of patients with measurable disease.
    • To evaluate the overall response rate (ORR) by immune RECIST, including confirmed and unconfirmed, complete and partial response, of patients treated with olaparib + pembrolizumab compared to olaparib alone, in the subset of patients with measurable disease.
    • To evaluate the duration of response (DoR) by RECIST 1.1 in patients treated with olaparib + pembrolizumab compared to olaparib alone.

    Banking Objective:

    • To bank tissue and blood specimens for future correlative studies.
    Cancer Categories:
    • Gastrointestinal (GI)
    Principal Investigator:
    • Al Hallak, Mohammed
    Karmanos Trial ID:
    • S2001
    Age Group:
    • Adult
    Phase:
    • Phase II
  • 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 Phase II:

      To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with Sentinel Lymph Node (SLN) biopsy compared to Elective Neck Dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0).

    Primary Objectives Phase III:

    • To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0).
    • To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0).

    Secondary Objectives:

    • To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.
    • To measure and compare overall survival (OS) between surgical arms.
    • To measure and compare the toxicity of the two surgical arms.
    • To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms, using the following instruments:
      • Neck Dissection Impairment Index (NDII)
      • Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH)
      • Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N)
    • To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.
    • To estimate the negative predictive rate of FDG PET/CT for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.
    • To assess nodal metastases rates between arms.
    • To assess the pathologic false omission rate (FOR) in the SLN biopsy arm.
    • To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the NDII is superior with the SLN biopsy compared to the END in low-risk patients.
    Cancer Categories:
    • Head and Neck
    Principal Investigator:
    • Cramer, John
    Karmanos Trial ID:
    • NRG-HN006
    Age Group:
    • Adult
    Phase:
    • Phase II/III