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.

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Results 1 - 10 of 13

Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants with Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study
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
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A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors
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
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A Phase 1, Open-label Study of BS006, an Oncolytic Virus, Administered by Intratumoral Injection in Patients with Advanced/Metastatic Solid Tumors
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
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A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors that Express HER2
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
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An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Locally Advanced or Metastatic Solid Tumors
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
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A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL - 2 Superkine, Administered Alone or in Combination with Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors
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
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A Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma
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
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Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
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
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A Phase 1/2, open-label, multicenter, dose escalation and expansion study of SLC-3010 monotherapy and in combination with various anticancer therapies in patients with advanced solid tumors
Objective:

Part 1 Dose Escalation of SLC-3010 Monotherapy and in Combination

Primary Objectives:

To assess safety and tolerability of increasing dose levels ofSLC-3010

To define the maximum tolerated dose (MTD) or maximum administered dose (MAD), and recommended Phase 2 dose (RP2D)

Secondary Objectives:

To evaluate preliminary antitumor activity

To characterize single and multiple dose PK of SLC-3010 and its metabolite TCB2 and IL-2

To assess immunogenicity to SLC-3010

Part 2: Dose Expansion of SLC-3010 Monotherapy and in Combination

Primary Objectives:

To evaluate efficacy of SLC-3010 and the combination.

Secondary Objectives:

To evaluate anti-tumor activity

To assess safety and tolerability of SLC-3010 at RP2D

To characterize single and multiple dose PK of SLC-3010 and its metabolite TCB2 and IL-2

To assess immunogenicity to SLC-3010
Cancer Categories:
Brain and Nervous System,Breast,Genitourinary (GU),Head and Neck,Lung,Skin
Principal Investigator:
Winer, Ira
Karmanos Trial ID:
2022-073
Age Group:
Adult
Phase:
Phase I/II
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A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes
Objective:

Primary Objectives:

To determine clinical benefit as described by the overall response rate (ORR) of nab-sirolimus via independent radiographic review (IRR) in patients with malignant solid tumors with pathogenic inactivating alterations in TSC1 or TSC2 genes

Secondary Objectives:

To evaluate the duration of response (DOR), disease control rate (DCR), time to response (TTR), and progression-free survival (PFS) via IRR, and overall survival (OS) of nab-sirolimus

To evaluate changes in Quality-of-Life

To describe the safety and tolerability of nab-sirolimus
Cancer Categories:
Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung,Skin
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2022-030
Age Group:
Adult
Phase:
Phase II
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