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 13

  • 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:

    • To investigate the safety of monotherapy and T- Plex combination TCR-Ts
    • To determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

    Secondary Objectives:

    • To investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts
    • To investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts
    Cancer Categories:
    • Gynecologic,Hematologic (Blood Cancers),Lung,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2023-086
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • To evaluate the safety and tolerability of BS006 in patients with advanced solid tumors
    • To estimate the maximum tolerated dose (MTD) of BS006

    Secondary Objectives:

    • To preliminarily observe the anti-tumor efficacy of BS006 in patients with advanced solid tumors
    • To evaluate the biological activities of BS006 in tumor
    • To evaluate the biodistribution and viral shedding of BS006
    Cancer Categories:
    • Breast,Skin
    Principal Investigator:
    • Elayoubi, Jailan
    Karmanos Trial ID:
    • 2023-076
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • To determine the safety and tolerability of ASP1012 (┬▒pembrolizumab) in participants with locally advanced or metastatic solid tumors
    • To determine the MTD and/or candidate RP2D of ASP1012

    Secondary Objectives:

    • To evaluate the PK and virus shedding of ASP1012
    • To evaluate the ADAs of ASP1012
    • To evaluate anti-tumor effects of ASP1012
    • To evaluate tumor-specific virus delivery
    • To evaluate tumor biomarker changes related to ASP1012 treatment (CRC and ovarian)
    Cancer Categories:
    • Gastrointestinal (GI),Gynecologic,Skin
    Principal Investigator:
    • Shields, Anthony
    Karmanos Trial ID:
    • 2023-093
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Dose Escalation (Monotherapy)

    Primary Objectives:

    • To evaluate safety and tolerability of MDNA11 administered in patients with advanced solid tumors
    • To identify RDE and/or MTD of MDNA11.

    Secondary Objectives:

    • To assess anti-tumor activity of MDNA11
    • To assess pharmacokinetic (PK) profile of MDNA11
    • To assess immunogenicity of MDNA11
    • To assess pharmacodynamic effects of MDNA11

    Dose Expansion (Monotherapy and Combination Therapy)

    Primary Objectives:

    • To further evaluate safety and tolerability of MDNA11 (alone or in combination with pembrolizumab)
    • To assess anti-tumor activity of MDNA11 (alone or in combination with pembrolizumab)

    Secondary Objectives:

    • To assess pharmacodynamic effects of MDNA11 (alone or in combination pembrolizumab) in peripheral blood
    • To assess pharmacodynamic effects and immune response of MDNA11 (alone or in combination pembrolizumab) in tumor tissue
    • To further assess PK profile of MDNA11
    • To assess immunogenicity of MDNA11 (alone or in combination pembrolizumab)
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2023-053
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objective:

    • To evaluate the antitumor activity of disitamab vedotin in subjects with previously treated, locally-advanced unresectable or metastatic (LA/m) HER2 expressing solid tumors

    Secondary Objectives:

    • To evaluate the safety and tolerability profile of disitamab vedotin
    • To assess other measures of antitumor activity of disitamab vedotin per investigator assessment by other clinically relevant measures
    • To evaluate the pharmacokinetics (PK) of disitamab vedotin
    • To evaluate the immunogenicity of disitamab vedotin
    Cancer Categories:
    • Gastrointestinal (GI),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • 2023-069
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Efficacy Objectives:

    • To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured using assessments by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Secondary Efficacy Objectives:

    • To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured using survival
    • To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured using assessments by the BIRC per RECIST v1.1
    • To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured using assessments by the investigator per RECIST v1.1
    Cancer Categories:
    • Skin
    Principal Investigator:
    • Shao, Yusra
    Karmanos Trial ID:
    • 2023-048
    Age Group:
    • Adult
    Phase:
    • Phase III
  • 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:

    Part A

    Primary Objectives:

    • To characterize the safety and tolerability of GV20-0251 and establish the MTD and/or the RP2D of GV20-0251

    Secondary Objectives:

    • To characterize the PK of GV20-0251
    • To characterize the immunogenicity of antiGV20-0251 ADA and nADA
    • To evaluate the preliminary anti-tumor activity of GV20-0251

    Part B

    Primary Objectives:

    • To evaluate the ORR per RECIST version 1.1 of GV20-0251 in different tumor types

    Secondary Objectives:

    • To characterize the safety of GV20-0251
    • To characterize the PK of GV20-0251
    • To characterize the immunogenicity of GV20-0251
    • To evaluate the anti-tumor activity of GV20-0251
    Cancer Categories:
    • Gastrointestinal (GI),Genitourinary (GU),Head and Neck,Lung,Skin
    Principal Investigator:
    • Al Hallak, Mohammed
    Karmanos Trial ID:
    • 2023-106
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • Parts A, B, and C: Evaluate antitumor activity of tisotumab vedotin as a single agent as measured by investigator-determined confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    • Part D: Evaluate antitumor activity of tisotumab vedotin in combination with pembrolizumab or with both pembrolizumab and carboplatin, as measured by investigator-determined confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Secondary Objectives:

    Parts A, B, and C:

    • Evaluate preliminary antitumor activity of tisotumab vedotin as a single agent, as measured by confirmed and unconfirmed ORR
    • Evaluate the safety and tolerability of tisotumab vedotin as a single agent, as measured by type, incidence, severity, seriousness, and relatedness of adverse events (AEs)

    Part D:

    • Evaluate preliminary antitumor activity of tisotumab vedotin in combination with pembrolizumab or with both pembrolizumab and a platinum agent (carboplatin or cisplatin), as measured by confirmed and unconfirmed ORR, per RECIST v1.1
    • Evaluate the safety and tolerability of tisotumab vedotin in combination with pembrolizumab or with both pembrolizumab and carboplatin, as measured by type, incidence, severity, seriousness, and relatedness of adverse events (AEs)
    • Evaluate preliminary safety and tolerability of tisotumab vedotin in combination with pembrolizumab and cisplatin

    All Parts of Study:

    • Assess pharmacokinetics (PK) and immunogenicity of tisotumab vedotin
    • Evaluate stability and control of disease as measured by disease control rate (DCR)
    • Evaluate durability of response as measured by duration of response (DOR)
    • Evaluate timing of response as measured by time to response (TTR)
    • Assess progression-free survival (PFS)
    • Assess survival as measured by overall survival (OS)

    Additional Objectives:

    • Assess Tissue Factor (TF) expression-response relationship
    • Assess biomarkers of biological activity and resistance and predictive biomarkers of response
    • Evaluate patient reported outcomes (PRO) and health-related quality of life (HRQOL) for Part D only
    Cancer Categories:
    • Gastrointestinal (GI),Head and Neck,Lung,Skin
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • 2023-029
    Age Group:
    • Adult
    Phase:
    • Phase II