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 23

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
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
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A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS >=20) (HexAgon-HN)
Objective:

Primary Objective:

To compare the efficacy of INBRX-106 + pembrolizumab vs pembrolizumab

Secondary Objective:

To further compare the efficacy of INBRX-106 + pembrolizumab vs pembrolizumab

To evaluate the safety and tolerability of INBRX-106 + pembrolizumab vs pembrolizumab

To compare the impact of INBRX-106 + pembrolizumab vs pembrolizumab on pain, function, and HRQoL
Cancer Categories:
Head and Neck
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
2024-066
Age Group:
Adult
Phase:
Phase II/III
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A phase 3 open-label, randomized, controlled study to evaluate the efficacy and safety of petosemtamab compared with investigator's choice monotherapy treatment in previously treated patients with incurable, metastatic/recurrent head and neck squamous cell carcinoma
Objective:

Primary Objectives:

To compare antitumor activity in ORR per
Response Evaluation Criteria in Solid Tumor
(RECIST) Guidelines version (v) 1.1 as assessed
by blinded independent central review (BICR)
in patients with incurable metastatic /
recurrent HNSCC patients progressed on after
anti-PD-1 and platinum containing therapy,
treated with petosemtamab monotherapy vs
investigator’s choice monotherapy

To compare OS in patients with incurable
metastatic / recurrent HNSCC progressed on
after anti-PD-1 and platinum-containing
therapy, treated with petosemtamab
monotherapy vs investigator’s choice
monotherapy

Secondary Objectives:

To evaluate antitumor activity in ORR per
RECIST v1.1 as assessed by investigator review

To evaluate antitumor activity in DOR per
RECIST v1.1 as assessed by BICR and
investigator review

To evaluate antitumor activity in TTR per
RECIST v1.1 as assessed by BICR and
investigator review

To evaluate antitumor activity in PFS per
RECIST v1.1 as assessed by BICR and by
investigator review

To evaluate antitumor activity in CBR per
RECIST v1.1 as assessed by BICR and by
investigator review

To evaluate safety and tolerability of
petosemtamab monotherapy

To evaluate patient health-related quality of
life (HRQL) using the European Organisation
for Research and Treatment of Cancer (EORTC)
validated Quality of Life of Cancer Patients
Questionnaire (QLQ-C30)

To evaluate patient HRQL using the updated
EORTC validated Quality of Life of Head and
Neck Cancer Patients Questionnaire (QLQH&N43)

To characterize the PK of petosemtamab

To characterize the population PK of
petosemtamab

To characterize the immunogenicity of
petosemtamab
Cancer Categories:
Head and Neck
Principal Investigator:
Hadid, Tarik
Karmanos Trial ID:
2024-023
Age Group:
Adult
Phase:
Phase III
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Phase II Randomized Trial of Radiotherapy with or without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing
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
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A Phase 1 Study of CHS-114 in Participants with Advanced Solid Tumors
Objective:

Arm 1a and Arm 1b

Primary Objectives:

Select 2 doses of CHS-114 as a monotherapy to be considered as recommended dose for expansion (RDEs) in participants with advanced solid tumors and HNSCC following standard first-line therapy.

Secondary Objectives:

Evaluate the safety and tolerability of CHS114 monotherapy.

Evaluate the PK of CHS-114 as monotherapy.

Evaluate the preliminary antitumor activity of CHS-114 administered as monotherapy.

Evaluate the changes in FOXP3 levels within the tumor tissue (in participants undergoing pretreatment and on-treatment tumor biopsies).

Arm 2

Primary Objectives:

Evaluate the safety and tolerability of CHS-114 in combination with toripalimab in participants with HNSCC following standard first-line therapy

Secondary Objectives:

Evaluate the PK of CHS-114 and toripalimab when administered in combination.

Evaluate the preliminary antitumor activity of CHS-114 administered in combination with toripalimab.
Cancer Categories:
Head and Neck
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
2023-099
Age Group:
Adult
Phase:
Phase I
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A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors
Objective:

Primary Objectives:

To evaluate the safety and tolerability of FT825 with or without cetuximab following CY/FLU or bendamustine

To define the RP2D of FT825 with or without cetuximab following CY/FLU or bendamustine

Secondary Objectives:

To evaluate the antitumor activity of FT825 with or without cetuximab following CY/FLU or bendamustine

To characterize the PK of FT825 with or without cetuximab following CY/FLU or bendamustine
Cancer Categories:
Breast,Gastrointestinal (GI),Head and Neck,Lung
Principal Investigator:
Assad, Hadeel
Karmanos Trial ID:
2023-100
Age Group:
Adult
Phase:
Phase I
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A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants with Advanced Malignancies
Objective:

Primary Objectives:

To assess the safety and tolerability of AB598 in participants with advanced malignancies

Secondary Objectives:

To describe the pharmacokinetic (PK) profile of AB598 in participants with advanced malignancies

To assess the immunogenicity to AB598 in participants with advanced malignancies

To assess the preliminary clinical activity of AB598 in patients with advanced malignancies
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2023-077
Age Group:
Adult
Phase:
Phase I
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A Phase II Multicenter Trial of ESK981 in Patients with Select Solid Tumors
Objective:

Primary Objectives:

Determine efficacy using proportion of patients alive and progression-free at 4 months within each cancer subtype

Secondary Objectives:

Determine overall response rate (ORR), duration of response (DoR), median progression-free survival (PFS) and overall survival (OS) within each cancer subtype

Determine safety and tolerability in each cancer subtype
Cancer Categories:
Gastrointestinal (GI),Genitourinary (GU),Head and Neck
Karmanos Trial ID:
2024-009
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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An Open-Label Study of GV20-0251 in Patients with Advanced and/or Refractory Solid Tumor Malignancies
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
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