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 26

  • 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: 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:

    • To evaluate tolerability of xevinapant when added to weekly cisplatin-based CRT in LA SCCHN

    Secondary Objectives:

    • To characterize safety of xevinapant when added to weekly cisplatin-based CRT in LA SCCHN
    • To evaluate clinical activity parameters using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
    • To evaluate time to subsequent cancer treatments in participants treated with xevinapant when added to weekly cisplatin-based CRT in LA SCCHN
    Cancer Categories:
    • Head and Neck
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • 2023-098
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • To assess the safety and tolerability of AB248 alone or in combination with pembrolizumab

    Secondary Objectives:

    • To assess the preliminary antitumor effect of AB248 alone or in combination with pembrolizumab
    • To assess the PK of AB248 alone or in combination with pembrolizumab
    • To assess the relationship between AB248 PK and biomarkers of pharmacodynamic response to AB248 alone or in combination with pembrolizumab
    • To assess the immunogenicity of AB248 when administered alone or in combination with pembrolizumab
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Head and Neck,Lung,Skin
    Principal Investigator:
    • Hadid, Tarik
    Karmanos Trial ID:
    • 2023-090
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objectives

    • To evaluate MPR of TransCon TLR7/8 Agonist in combination with pembrolizumab and TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ as compared with pembrolizumab monotherapy

    Secondary Objectives

    • To evaluate the anti-tumor activity of TransCon TLR7/8 Agonist in combination with pembrolizumab and TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ as compared with pembrolizumab monotherapy
    • To evaluate the safety and tolerability of TransCon TLR7/8 Agonist in combination with pembrolizumab and TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ
    Cancer Categories:
    • Head and Neck,Lung
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • 2023-085
    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 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 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:

    Module A Monotherapy—dose escalation

    Primary Objective:

    • To investigate the safety and tolerability of EP0031 given as monotherapy

    Secondary Objective:

    • To characterize the PK of EP0031 given as monotherapy, after a single dose and at steady state after multiple dosing

    Modules B and C Monotherapy—dose expansion

    Primary Objective:

    • To assess the efficacy of EP0031 given as monotherapy in patients with RET-altered tumours who have progressed following firstgeneration SRI therapy and in patients with RET-altered tumors with no prior SRI therapy (by RECIST v1.1)

    Secondary Objectives:

    • To investigate the safety and tolerability of EP0031 given as monotherapy
    • To characterize the PK of EP0031 given as monotherapy
    Cancer Categories:
    • Gastrointestinal (GI),Head and Neck,Lung
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • 2023-066
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objectives:

    • To evaluate the safety and tolerability of SGN-PDL1V in subjects with advanced solid tumors.
    • To identify the maximum tolerated dose (MTD) of SGN-PDL1V in subjects with advanced solid tumors.
    • To identify a recommended dose and schedule for SGN-PDL1V.

    Secondary Objectives:

    • To assess the antitumor activity of SGN-PDL1V.
    • To assess the pharmacokinetics (PK) of SGN-PDL1V.
    • To assess the immunogenicity of SGN-PDL1V.
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Head and Neck,Lung
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • 2023-045
    Age Group:
    • Adult
    Phase:
    • Phase I