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 49

Phase I Trial of Accelerated or Conventionally Fractionated Radiotherapy Combined With MEDI4736 (Durvalumab) in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (ARCHON-1)
Objective:

Primary Objective

To evaluate if the addition of MEDI4736 (durvalumab) to two schedules of radiation therapies (60 Gy in 30 fractions or 60 Gy in 15 fractions) is safe.

Secondary Objectives

To examine if the addition of MEDI4736 (durvalumab) to radiation therapy is feasible.

To assess toxicities associated with the addition of MEDI4736 (durvalumab) to radiation therapy.

To obtain preliminary estimates of progression-free survival (PFS), using RECIST guidelines, in patients who received MEDI4736 (durvalumab) added to radiation. Although the clinical benefit of MEDI4736 (durvalumab) in combination with radiotherapy has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response.
Cancer Categories:
Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-LU004
Age Group:
Adult
Phase:
Phase I
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Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed By Concurrent Mediastinal Chemoradiation For Locally Advanced Non-Small Cell Lung Cancer
Objective:

Primary Objectives:

To compare the overall survival in patients with stage II-IIIC inoperable nodepositive
non-small cell lung cancer (NSCLC) after image guided, motion-managed
conventional radiotherapy to the primary tumor and nodal metastases (Arm 1) or after
image guided, motion-managed stereotactic body radiation therapy (SBRT) to the
primary tumor followed by conventionally fractionated radiotherapy to nodal
metastases (Arm 2) both given with concurrent platinum-based chemotherapy.

To compare progression-free survival between the experimental arm (Arm 2) and
control arm (Arm 1).

Secondary Objectives:

To compare objective response rate (as defined by RECIST v 1.1) between the
experimental arm and control arm

To compare the rate of local control between the experimental arm and control arm

To compare patterns of failure (primary, locoregional, or distant) between the
experimental arm and control arm

To compare changes in pulmonary function (FEV1 and DLCO assessed at
randomization and at 6 and 12 months following completion of radiation therapy)
between the experimental arm and control arm

To compare changes in quality of life and patient-reported outcomes assessed from
pre-treatment to 3 months following radiation therapy of each treatment arm

To determine acute and late toxicity profiles of each treatment arm as measured by
the CTCAEv5
Cancer Categories:
Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-LU008
Age Group:
Adult
Phase:
Phase III
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PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
Objective:

Primary Objective:

To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for Stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care.

Secondary Objective:

To summarize reports of serious and unexpected high-grade (≥ Grade 3) treatment-related adverse events determined by the treating physician within each treatment arm.
Cancer Categories:
Lung
Principal Investigator:
Mamdani, Hirva
Karmanos Trial ID:
S2302
Age Group:
Adult
Phase:
Phase II
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Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial
Objective:

Primary Objective

Phase II:

To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone

Phase III:

To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone

Secondary Objectives

To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm

To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and >3 visible tumors

To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease (“complete consolidation”) and patients who do not receive consolidation radiation to all visible disease (“incomplete consolidation”)
Cancer Categories:
Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-LU007
Age Group:
Adult
Phase:
Phase II/III
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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 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 I, Open-label, Multicenter Study of ZL-1218 as a Single Agent and as Combination Therapy with Anti-PD-1 Antibody to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Advanced Solid Tumor Malignancies
Objective:

Primary Objectives:

To characterize the safety and tolerability of different dose levels of ZL-1218 when administered as a single agent and in combination with pembrolizumab (200 mg IV Q3 week), including dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD) of ZL-1218.

Secondary Objectives:

To assess the preliminary efficacy of ZL-1218 when administered as a single agent and in combination with pembrolizumab.

To characterize the pharmacokinetics (PK) of ZL-1218 as a single agent or in combination with pembrolizumab, after a single dose and multiple doses.

To evaluate the immunogenicity of ZL-1218 as a single agent or in combination with pembrolizumab, after a single dose and multiple doses.
Cancer Categories:
Gastrointestinal (GI),Genitourinary (GU),Head and Neck,Lung
Principal Investigator:
Mamdani, Hirva
Karmanos Trial ID:
2023-081
Age Group:
Adult
Phase:
Phase I
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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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BelieveIT-201: A Randomized, Phase 2, Open-label Trial of TransCon TLR7/8 Agonist in Combination with Pembrolizumab, TransCon TLR7/8 Agonist in Combination with TransCon IL-2 B/y, or Pembrolizumab Monotherapy as Neoadjuvant Therapy in Participants with Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
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
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