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 24

  • Objective:
    Primary Objective:
    Phase II
    • To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin).
    Phase III
    • To demonstrate co-primary endpoints of non-inferiority of PFS and superiority of quality of life (QOL) as measured by the MDADI of concurrent reduced-dose radiation with cisplatin or concurrent reduced-dose radiation with nivolumab to the current standard of care (standard-dose RT with cisplatin).
    Secondary Objectives:
    • To compare patterns of failure (local and regional relapse versus distant) and overall survival between each experimental arm and the control arm;
    • To assess long term PFS, overall survival, and toxicity between each experimental arm and the control arm;
    • To determine acute and late toxicity profiles as measured by the CTCAE;
    • To explore the symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the PRO-CTCAE;
    • To compare changes in patient-reported outcomes (HHIA-S, EORTC-QLQ30) between each experimental arm and the control arm;
    • To assess the association of FDG-PET/CT at baseline with locoregional control and PFS;
    • To estimate the negative predictive value of the 12-14 weeks post-RT FDG-PET/CT in terms of locoregional control rates and PFS rates at 1 and 2 years.
    Cancer Categories:
    • Head and Neck
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • NRG-HN005
    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
  • Objective:
    Primary Objectives:
    • To evaluate OS of adjuvant reirradiation plus concurrent pembrolizumab followed by pembrolizumab to complete 12 months total of pembrolizumab to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk HNSCC patients.
    • To evaluate OS of adjuvant pembrolizumab for 12 months compared to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk HNSCC patients.
    Secondary Objectives:
    • To evaluate the following endpoints in all arms: DFS, Locoregional control, Rates of distant metastasis, Toxicity.
    • To evaluate whether high PD-L1 expression (defined as CPS ≥ 20) is predictive of increased efficacy in the experimental groups compared to control.
    Cancer Categories:
    • Head and Neck
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • EA3191
    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
  • Objective:
    Primary Objectives:
    • Evaluate the structure preservation rate for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy; all patients will undergo surgical resection and postoperative standard care.
    • Evaluate overall survival (OS) for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy followed by surgical resection and postoperative standard care.
    Secondary Objectives:
    • Evaluate progression-free survival (PFS) for this patient population.
    • Examine the rate of structure preservation for the orbit (freedom from orbital exenteration).
    • Evaluate site reported p16 data and correlate with outcome.
    • Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of orbit and skull base preservation.
    • Determine the accuracy of baseline/post-chemotherapy MRI and/or FDG PET/CT-based prediction of 2-year overall survival.
    Cancer Categories:
    • Head and Neck
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • EA3163
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Objective:

    • To evaluate the disease-free survival (DFS) of patients with stage III-IV SCCHN and disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin.

    Secondary Objectives:

    • To evaluate the DFS of patients with stage III-IV SCCHN and non-disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin
    • To evaluate the DFS of patients with stage III-IV SCCHN and p53 wild type after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin
    • To evaluate toxicities of PORT alone or PORT with concurrent cisplatin.
    • To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin.
    • To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach.
    Cancer Categories:
    • Head and Neck,Lung
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • EA3132
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Objective:

    • Our long-term goal is to improve outcomes for individuals suffering from LEF. The overall objective for this study is to conduct a randomized clinical trial comparing the effectiveness of APCD and Usual Care for the management of LEF
    Cancer Categories:
    • Head and Neck
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • 2022-047
    Age Group:
    • Adult
    Phase:
    • NA
  • 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:

    • 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
  • Objective:

    Primary Objectives:

    • To assess the OS of buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC

    Secondary Objectives:

    • To evaluate additional efficacy parameters including progression free survival (PFS), overall response rate (ORR), and duration of response (DoR) by the Investigator and Independent Radiological Review Committee (IRRC).
    • To evaluate efficacy parameters in subgroups of patients defined by the randomization strata.
    • To assess the effect of buparlisib in combination with paclitaxel on patient’s symptoms and healthrelated quality of life (HRQoL).
    • To assess biomarkers of response to buparlisib in combination with paclitaxel.
    • To assess the pharmacokinetics (PK) of buparlisib in combination with paclitaxel.
    Cancer Categories:
    • Head and Neck
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • 2021-074
    Age Group:
    • Adult
    Phase:
    • Phase III