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 179

  • Objective:

    Primary Objective:

    • To determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX®. In patients with 1-3 positive nodes, and hormone receptor (HR)-positive, HER2-negative breast cancer with RS ≤ 25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for recommending chemotherapy or not.
    Cancer Categories:
    • Breast
    Principal Investigator:
    • Flaherty, Lawrence
    Karmanos Trial ID:
    • S1007
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:
    Primary Objective:
    • To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin, vinblastine, dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).
    Secondary Objectives:
    • To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.
    • To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.
    • To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.
    • To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.
    • To compare patient-reported symptoms using selected PRO-CTCAE items between arms stratified by age groups.
    • To compare the safety and tolerability of N-AVD versus that of BV-AVD.
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Modi, Dipenkumar
    Karmanos Trial ID:
    • S1826
    Age Group:
    • Both
    Phase:
    • Phase III
  • Objective:
    Primary Objective:
    • To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients.
    Secondary Objectives of First Randomization:
    • To compare the best overall response rate (ORR), including partial remission (PR), very good partial remission (VGPR), and complete remission (CR, sCR) in the subset of patients not in PR at randomization to lenalidomide versus lenalidomide + daratumumab/rHuPH20 in this patient population.
    • To compare progression-free survival (PFS) between the study arms in this patient population.
    • To evaluate MRD-negativity on the two treatment arms at randomization (Registration Step 2), and to compare MRD-negativity rate at 12, 24 (second randomization), 36, and 48 months after first randomization between lenalidomide and lenalidomide + daratumumab/rHuPH20 in this patient population.
    • To compare toxicities and tolerability of long term therapy between the study arms.
    Objectives of Second Randomization:
    • To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide vs. discontinued lenalidomide from the time of second randomization in this patient population.
    • To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide + daratumumab/rHuPH20 vs. discontinued lenalidomide + daratumumab/rHuPH20 from time of second randomization in this patient population.
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Kin, Andrew
    Karmanos Trial ID:
    • S1803
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:
    Primary Objective(s):
    • To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy.
    Secondary Objective(s):
    • To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy.
    • To evaluate if prophylactic carvedilol compared with no intervention results in a longer time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac dysfunction or events.
    • To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction OR events in this population.
    • To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction (see Section 11.2).
    • To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons.
    Cancer Categories:
    • Breast
    Principal Investigator:
    • Assad, Hadeel
    Karmanos Trial ID:
    • S1501
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objective:

    • To evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.

    Secondary Objectives:

    • To evaluate the safety and tolerability associated with the combination of olaparib + pembrolizumab vs. olaparib alone as maintenance therapy.
    • To evaluate the overall survival (OS) of patients treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.
    • To evaluate the overall response rate (ORR) by RECIST 1.1, including confirmed and unconfirmed, complete and partial response, of patients treated with olaparib + pembrolizumab compared to olaparib alone, in the subset of patients with measurable disease.
    • To evaluate the overall response rate (ORR) by immune RECIST, including confirmed and unconfirmed, complete and partial response, of patients treated with olaparib + pembrolizumab compared to olaparib alone, in the subset of patients with measurable disease.
    • To evaluate the duration of response (DoR) by RECIST 1.1 in patients treated with olaparib + pembrolizumab compared to olaparib alone.

    Banking Objective:

    • To bank tissue and blood specimens for future correlative studies.
    Cancer Categories:
    • Gastrointestinal (GI)
    Principal Investigator:
    • Al Hallak, Mohammed
    Karmanos Trial ID:
    • S2001
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:
    Primary Objective:
    • The primary goal of this study is to determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.
    Secondary Objectives:
    • To compare the rates of biochemical failure, an alternative biochemical failure endpoint, hormone-refractory disease (HRD), distant metastasis, cause-specific mortality, and overall mortality between patients who receive SRT with standard GnRH analog-based ADT and those who receive SRT with enhanced ADT.
    • To compare acute and late physician- and patient-reported toxicity between patients who receive SRT with standard GnRH analog-based ADT and those who receive SRT with enhanced ADT.
    • To compare fatigue using the PROMIS-F SF 7a between patients who receive SRT with standard GnRH analog-based ADT and those who receive SRT with enhanced ADT.
    • To assess global quality of life using the EQ-5D-5L between patients who receive SRT with standard GnRH analog-based ADT and those who receive SRT with enhanced ADT.
    Cancer Categories:
    • Genitourinary (GU)
    Principal Investigator:
    • Yeh, Brian
    Karmanos Trial ID:
    • RTOG3506
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:
    Primary Objective
    To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germ-line mutations.

    Secondary Objectives
    • To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACTES sub-scale compared to women in the BSO arm.
    • To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients.
    • To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.
    • To assess adverse events, graded using CTCAE v5.0.
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • NRG-CC008
    Age Group:
    • Adult
    Phase:
    • NA
  • Objective:

    Primary Objectives:

    • To compare the 3-year recurrence-free survival of women with high intermediate risk (HIR) Stage I/II mismatch repair deficient (dMMR) endometrioid endometrial cancer treated with radiation and MK-3475 (pembrolizumab) versus radiation alone.

    Secondary Objectives:

    • To describe the safety and tolerability of concurrent MK-3475 (pembrolizumab) and radiation compared to radiation alone in patients with MMR deficient high intermediate risk endometrial cancer (HIR EC).
    • To describe the recurrence patterns in each group.
    • To measure recurrence free survival at 5 years in each group.
    • To estimate disease specific overall survival in each group.
    • To determine whether the addition of MK-3475 (pembrolizumab) to radiation, compared with radiation alone is associated with decreased quality of life at 6- and 24-weeks, as measured with the FACT-En TOI, increased GI symptoms as measured with the GI subscale, and increased fatigue as measured with the PROMIS-Fatigue scale (short form).
    • To validate the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) subscale, which assesses in cancer patients on immunotherapy.
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Gogoi, Radhika
    Karmanos Trial ID:
    • NRG-GY020
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:
    Primary Objective
    • To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single agent cediranib as measured by progression free survival (PFS), in patients with recurrent, persistent or metastatic endometrial cancer.
    Secondary Objectives
    • 1.2.1 To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single-agent cediranib as measured by overall survival (OS) in patients with recurrent, persistent or metastatic endometrial cancer.
    • 1.2.2 To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment versus single-agent cediranib as measured by response rate in patients with recurrent, persistent or metastatic endometrial cancer.
    • 1.2.3 To assess the safety and tolerability of single–agent cediranib, single-agent olaparib, and the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment).
    • 1. 2.4 To assess if mutations in DNA Homologous Repair Genes (assayed prior to all treatment and prior to the study treatment) are predictive of response to olaparib alone or in combination with cediranib. (Integrated Biomarker)
    • 1.2.5 To assess if markers of angiogenesis in serial plasma samples are associated with response to cediranib alone or in combination with olaparib. (Integrated Biomarker)
    Cancer Categories:
    • Gynecologic
    Principal Investigator:
    • Gogoi, Radhika
    Karmanos Trial ID:
    • NRG-GY012
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:
    Primary Objective:
    Phase II
    • To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin).
    Phase III
    • To demonstrate co-primary endpoints of non-inferiority of PFS and superiority of quality of life (QOL) as measured by the MDADI of concurrent reduced-dose radiation with cisplatin or concurrent reduced-dose radiation with nivolumab to the current standard of care (standard-dose RT with cisplatin).
    Secondary Objectives:
    • To compare patterns of failure (local and regional relapse versus distant) and overall survival between each experimental arm and the control arm;
    • To assess long term PFS, overall survival, and toxicity between each experimental arm and the control arm;
    • To determine acute and late toxicity profiles as measured by the CTCAE;
    • To explore the symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the PRO-CTCAE;
    • To compare changes in patient-reported outcomes (HHIA-S, EORTC-QLQ30) between each experimental arm and the control arm;
    • To assess the association of FDG-PET/CT at baseline with locoregional control and PFS;
    • To estimate the negative predictive value of the 12-14 weeks post-RT FDG-PET/CT in terms of locoregional control rates and PFS rates at 1 and 2 years.
    Cancer Categories:
    • Head and Neck
    Principal Investigator:
    • Sukari, Ammar
    Karmanos Trial ID:
    • NRG-HN005
    Age Group:
    • Adult
    Phase:
    • Phase II/III