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 48

  • 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
  • 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
  • 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
  • Objective:

    Phase 1a (Dose Escalation)

    Primary Objectives:

    • To assess the safety and tolerability of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT) in patients with solid tumors
    • To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended doses for expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with cCRT

    Secondary Objectives:

    • To assess the preliminary antitumor activity of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with cCRT
    • To characterize the pharmacokinetic (PK) profile of BGB-24714 and its major metabolite BGB-22437 following the administration of capsules as monotherapy, in combination with chemotherapy, and in combination with cCRT

    Phase 1b (Dose Expansion)

    Primary Objectives:

    • To assess the preliminary antitumor activity of BGB-24714 in combination with chemotherapy in patients with selected solid tumors

    Secondary Objectives:

    • To further evaluate the secondary measures of antitumor activity of BGB-24714 in combination with chemotherapy in patients with selected solid tumors
    • To further characterize the safety and tolerability of BGB-24714 in combination with chemotherapy in patients with selected solid tumors
    • To further characterize the PK profile of BGB-24714 and its major metabolite in combination with chemotherapy in patients with selected solid tumors
    Cancer Categories:
    • Gynecologic,Lung
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2024-057
    Age Group:
    • Adult
    Phase:
    • Phase I
  • 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:

    • To determine the safety and tolerability of OBI-992 when administered intravenously (IV) to subjects with advanced solid tumors
    • To determine the maximum tolerated dose (MTD) and optimal recommended Phase 2 dose (RP2D) of OBI-992 using randomized assignment to 2 dose level cohorts and assessment of activity, safety, and tolerability for each cohort
    • To evaluate the preliminary clinical activity profile of OBI-992 (objective response rate [ORR], clinical benefit rate [CBR], duration of response [DOR], disease control rate [DCR], and progression-free survival [PFS])

    Secondary Objectives:

    • To determine the serum pharmacokinetics (PK) of OBI-992 and its active metabolite exatecan
    • To evaluate the immunogenicity of OBI992 (anti-drug antibodies [ADAs])
    Cancer Categories:
    • Gastrointestinal (GI),Lung
    Principal Investigator:
    • Saif, Wasif
    Karmanos Trial ID:
    • 2024-037
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objective:

    • To characterize the safety and tolerability of different dose levels of ZL-1310, including dose‑limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose (RD).

    Secondary Objectives:

    • To assess the preliminary efficacy of ZL-1310.
    • To characterize the pharmacokinetics (PK) of ZL-1310 as a single agent, after a single dose and multiple doses.
    Cancer Categories:
    • Lung
    Principal Investigator:
    • Mamdani, Hirva
    Karmanos Trial ID:
    • 2024-024
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives

    • To assess the safety and tolerability and determine the maximum-tolerated dose (MTD) and/or the RP2D of INBRX-106 as a single agent administered as an IV infusion in adult subjects with locally advanced or metastatic solid tumors.
    • To assess the safety and tolerability and determine the MTD and/or the RP2D of INBRX-106 in combination with pembrolizumab administered as an IV infusion in adult subjects with locally advanced or metastatic solid tumors.
    • To assess the safety and tolerability of INBRX-106 in combination with pembrolizumab and chemotherapy regimens in adult subjects with locally advanced or metastatic NSCLC.
    • To assess the antitumor activity of INBRX-106 in combination with pembrolizumab. (Part 4 Cohorts F3 and F4)

    Secondary Objectives

    • To assess the PK of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy.
    • To assess the immunogenicity of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy.
    • To assess the preliminary antitumor activity of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy. (All cohorts except F3 and F4)
    Cancer Categories:
    • Lung
    Principal Investigator:
    • Mamdani, Hirva
    Karmanos Trial ID:
    • 2024-043
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • 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
  • Objective:

    Primary Objectives:

    • To assess the safety and tolerability of study drug
    • To identify the recommended dose(s) (RD[s]) and schedule(s) that is (are) safe and biologically effective for study drug administered by intravenous (IV) dosing
    • To identify the RD(s) and schedule(s) that is (are) safe and biologically effective for study drug administered by subcutaneous (SC) dosing

    Secondary Objectives:

    • To characterize the pharmacokinetics (PK) of study drug administered by IV dosing
    • To characterize the PK of study drug administered by SC dosing
    • To assess the preliminary antitumor activity of study drug
    Cancer Categories:
    • Gastrointestinal (GI),Gynecologic,Lung
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2024-013
    Age Group:
    • Adult
    Phase:
    • Phase I