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Quantum Leap Healthcare Collaborative Concludes Cenicriviroc Not Likely to Reduce Time to Recovery or Mortality in Critically Ill Patients in I-SPY COVID Trial

Quantum Leap Healthcare Collaborative (QLHC), the sponsor of the I-SPY COVID Trial, today announced that cenicriviroc (CVC) has been dropped from the trial due to futility, based on the low likelihood of success. CVC was chosen for testing because it is a CCR2/5 inhibitor, which has been hypothesized to potentially prevent fibrosis linked to the inflammation that accompanies critical illness associated with COVID-19.

SAN FRANCISCO, April 28, 2021 /PRNewswire/ — Quantum Leap Healthcare Collaborative (QLHC), the sponsor of the I-SPY COVID Trial, today announced that cenicriviroc (CVC) has been dropped from the trial due to futility, based on the low likelihood of success. CVC was chosen for testing because it is a CCR2/5 inhibitor, which has been hypothesized to potentially prevent fibrosis linked to the inflammation that accompanies critical illness associated with COVID-19.

The I-SPY COVID Trial is a phase II, open label, adaptive platform trial being conducted in critically ill COVID-19 patients who are receiving high-flow oxygen or mechanical ventilation. The trial was designed to rapidly screen agents to find those with the best chance of reducing time to recovery (defined as reduction in oxygen demand) by approximately 50% and reducing risk of death. The I-SPY COVID Trial identified the initial agents for the study through a unique partnership with the COVID R&D Alliance, and CVC was the first oral agent identified and approved to go forward through this mechanism. The I-SPY COVID Trial included 18 sites at the time of evaluation, and there are now 26 participating sites.

QLHC discontinued testing of CVC in the I-SPY COVID Trial because, after 94 patients enrolled, the agent met the predefined futility criterion, defined as at least 90% probability that the hazard ratio for time to recovery is less than 1.5 compared to the control arm. The data from CVC patients were compared to those from 220 patients concurrently randomized to the control, which included backbone therapy (consisting of dexamethasone and remdesivir). Patients assigned to the CVC arm received backbone therapy in combination with 150 mg orally twice daily of CVC (load dose on Day 1 only of 450 mg) for a minimum of 14 days and up to 28 days. Based on a near final analysis of this interim data cut, there is a low probability that the addition of CVC to backbone therapy reduces time to recovery, as per pre-specified criteria for continuation.  Other endpoints assessed, including mortality, did not show a statistically significant difference between CVC and placebo at this interim data cut. As a result, the Data Monitoring Committee recommended closing the arm. The study did not identify new safety signals for CVC in the setting of critically ill patients.

Dr. D. Clark Files, an I-SPY COVID Trial co-investigator and chaperone (PI) of the CVC arm, and an associate professor of medicine at Wake Forest University (Winston Salem, North Carolina), commented, “The I-SPY COVID Trial demonstrated that CVC did not substantially improve recovery in patients critically ill with COVID-19. It is possible that this drug may be promising for treating other types of acute lung injury, or other populations of less critically ill COVID-19 patients and future trials may be warranted.” 

“While we were disappointed that CVC did not succeed in substantially altering the clinical course of patients with severe COVID-19 when added to dexamethasone and remdesivir, we were glad to know this quickly and continue to test other agents,” continued Dr. Sheetal Gandotra, an assistant professor of medicine at the University of Alabama at Birmingham and co-chaperone of the CVC arm of the I-SPY COVID Trial.

Kathleen Liu, a professor of medicine at UCSF and co-principal investigator for the I-SPY COVID Trial, added, “CVC did not meet the high bar we set for improving time to recovery. Finding effective agents for people who become critically ill from COVID-19 remains an urgent priority.”

“We were pleased to work with the I-SPY COVID Trial team and Quantum Leap Healthcare Collaborative to test an agent in our pipeline that had a chance to alter the course of this devastating condition,” said William Ferguson, PhD, Executive Director, Clinical Development, AbbVie.  “We are hopeful that some of the drugs being tested by I-SPY will prove helpful and safe in critically ill COVID-19 patients. This is a worthwhile endeavor and we appreciate the opportunity to be a part of the I-SPY network.” 

This study is a collaboration between members of Quantum Leap, the U.S. Food and Drug Administration and the COVID R&D Alliance, which AbbVie is a member of with more than 20 of the world’s leading biopharmaceutical and life science companies. In addition, the Biomedical Advanced Research and Development Authority (BARDA), part of HHS within the office of the Assistant Secretary for Preparedness and Response, and Joint Program Executive Office, a part of the Department of Defense, are also part of this collaboration under the Medical Chemical, Biological, Radiological, and Nuclear (CBRN) Defense Consortium (MCDC).

About Quantum Leap Healthcare Collaborative

‍Quantum Leap Healthcare Collaborative is a 501C(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to the I-SPY Trials. For more information, visit www.QuantumLeapHealth.org.

About the I-SPY Trials

‍The I-SPY Trials were designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 20 major U.S. medical research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org. 

SOURCE Quantum Leap Healthcare Collaborative

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For more information, email karyn.digiorgio@quantumleaphealth.org

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Tracey Heather

Advocate Liaison

As Patient Engagement Lead at Quantum Leap, I manage follow-up data projects for the I-SPY 2 Trial, develop strategies to strengthen patient engagement, and oversee the I-SPY Advocate group. After six successful years raising funds to support Quantum’s mission, I embraced this new role last summer, drawn by the opportunity to make a direct impact on the patients we serve. Each day brings new challenges and insights, and I especially enjoy supporting and collaborating with our inspiring I-SPY Advocates.

Outside of work, I am pursuing a Master of Public Administration with a focus on nonprofit management at SF State. I’m passionate about trail running, skiing, live music, camping, traveling, and collegiate gymnastics—my daughter competes at Oregon State. For the past 5 years, I have volunteered with SF CASA as a mentor to an incredible 18-year-old foster youth whose resilience continually reminds me of life’s true priorities.

Carolyn Clark Beedle

Carolyn Clark Beedle, a 2023 breast cancer survivor, joined the advocate program after successful completion of treatment with the UCSF Breast Oncology Program. Her experience working with a patient advocate during her TNBC treatment led to an understanding that empowering women to advocate for their own health and healthcare will contribute to improved health outcomes and broader access to care. Carolyn began advocating for cancer patients and their families during her treatment, now is a member of the Breast Science Advocacy Core (BSAC) with the UCSF Breast Oncology Program, and currently shares information and research with CFNP associates at La Clinica in the Bay Area to inform and empower their patient population.

Carolyn is continuing her on the ground training as an advocate reviewer with both Quantum Health and BSAC and is enrolled in the Patient Advocacy Training in Health Science course with Stanford Medicine. Her 30+ career in corporate marketing/communications, program development and non-profit leadership augmented by her breast cancer treatment experience serves Carolyn well in representing and communicating the patient voice and perspective.

She received her BA (History/English Lit) and MA (Public History/Research and Record Management) from the University of San Diego, is a proud fifth generation San Franciscan, and active board member with numerous non-profits that support social work and the arts.

Silver Alkhafaji

Silver Alkhafaji is a PhD candidate in the Pharmaceutical Sciences and Pharmacogenomics (PSPG) program at UCSF. She received her Bachelor of Science in Chemical Biology from UC Berkeley. Prior to UCSF, she worked in the Clinical Pharmacology Department at Genentech. Silver’s current research focuses on non-invasive liquid biopsies to predict response and side effects of immunotherapies and endocrine therapies in early-stage breast cancer participants in I-SPY 2.

Silver is interested in clinical outcomes research to advance precision medicine and improve cancer patients’ quality of life. She is passionate about health equity, inclusive research, patient advocacy, and women’s health.
Silver volunteers at the Patient and Family Cancer Support Center at UCSF where she assists in patient navigation and connecting patients and their families with resources that improve their healthcare experience while receiving cancer treatments and/or during survivorship. 

Through her DEI work in her PhD program, Silver raises awareness around issues related to social justice and community building through organizing community-centered events. Additionally, she is a member of the Life Sciences Career Advisory Council at Thrive Scholars, where she enjoys supporting college students of color from economically disadvantaged communities in providing the opportunities they need to thrive at top colleges and in high-trajectory careers. 

Silver is a member of the American Association of University Women (AAUW) Alameda Branch where she focuses her efforts on increasing membership of community college women coming from exceptional backgrounds: student parents, low-income, and first-generation college students.

In her free time, she writes poetry and prose on emotional healing, radical acceptance, and patience. Writing has helped her process difficult situations and connect with people on a deeper level.

Jane Mortimer

Jane is a breast cancer survivor and advocate dedicated to positively impacting the lives of women affected by the disease. Diagnosed with triple negative breast cancer in 2012, she participated in the I-SPY 2 trial at UCSF and has been cancer free for more than ten years.

Her advocacy journey began in 2003 at UCSF as a volunteer with the Patient and Family Cancer Support Center and Decision Support Services and she previously managed the Peer Support program at UCSF. Drawing on her experience in marketing and media strategy, she uses her skills to make a meaningful impact by supporting advocacy and research that improves outcomes for women living with breast cancer.

Jan Tomlinson

In March of 2023 , Jan was diagnosed with a large aggressive triple negative breast cancer and informed that her cancer was the” bad girl” of cancer and offered standard chemotherapy for 24 weeks. Devasted by the diagnosis Jan felt like she had a dire prognosis. After seeking several opinions, she opted to join a Clinical Trial program for her treatment. The trial consisted of significantly less chemotherapy, and monitored closely over a 12-week period, The data predicted a complete pathological response , and she then went immediately to surgery. Pathology reports supported that she had a successful outcome reaching PCR meaning the tumor was gone, and no residual cancer was found in the surrounding tissue or lymph nodes. Jan was thrilled when her surgeon advised her of the results. The experience made Jan want to give back and share information that she received when she was at a critical juncture in her diagnosis. She is so passionate about making sure that everyone knows that the standard of care is one treatment option.

As she says, “ clinical trials have to be on the table” Because she achieved PCR, she expects a great outcome. She wants to share her story and encourage other women to strongly consider and participate in clinical trials. Jan is a UCSF Patient Advocate, involved in several programs they lead. Jan also is a BLACC Cab Member. Jan recently was in Washington DC to participate on a panel on Clinical Trials for ISPY at the National Press Club. UCSF will be hosting the RISE Up For Breast Cancer event where Jan will share her experience with clinical trials.

Deborah Collyar

Deb is a connector who founded Patient Advocates in Research (PAIR) “where research meets reality,” bringing ideas and people together for medical advances that offer real results for diverse patients and families.

Her vast experience between the worlds of tech, communication, strategy, management, policy, and equity bridges gaps between patients, scientists, medical providers, payers, governments, and non-profits.

Deb infuses patient engagement into projects, gathers relevant patient input, and encompasses many diseases, programs and policies at grassroots, national and international levels through companies, academia, and governments.

Key patient insights are delivered throughout discovery, development, clinical trials, results reporting, data-sharing, standards, genomics, and into practice.

Her experience spans translational and clinical research, epidemiology, health outcomes, and health delivery research with academia, federal agencies, companies, and patient communities.