Alliance Foundation Trials, LLC (AFT)

Alliance Foundation Trials, LLC (AFT) is a research organization that develops and conducts cancer clinical trials, working closely with the Alliance for Clinical Trials in Oncology scientific investigators and institutional member network, research collaborators, and non-NCI funding sources. AFT seeks to fulfill the vision of the Alliance for Clinical Trials in Oncology to reduce the impact of cancer on people by uniting a broad community of scientists and clinicians from many disciplines committed to discovering, validating, and disseminating effective strategies for the prevention and treatment of cancer. Established in 2014 as a limited liability corporation, AFT is the sole member of the Alliance for Clinical Trials in Oncology Foundation. Current AFT studies are funded by a number of pharmaceutical company collaborators and the Patient-Centered Outcomes Research Institute (PCORI).

** Note that participation in AFT is restricted to Alliance members in good standing that fulfill the specific study feasibility criteria.**

Here's a listing of current AFT trials.

PENDING AFT TRIALS
AFT-35: Phase I/II multicenter, open-label, dose-escalation study of the combination of pomalidomide, bortezomib, low-dose dexamethasone,
and daratumumab, in patients with relapsed or refractory multiple myeloma

Phase: Phase I/II | Study Chair: H. Hassoun

AFT-47: A randomized phase II study of androgen receptor directed therapy on cognitive function in patients treated with darolutamide or
enzalutamide

Phase: Phase II | Study Chair: A. Morgans and C. Ryan

AFT-50 A phase IB/II umbrella study of targeted agents with atezolizumab for patients with recurrent or persistent endometrial cancer
Phase: Phase 1B/II | Study Chair: B Slomovitz

AFT-51: Intraoperative molecular imaging of pulmonary nodules with tumorglow during pulmonary metastasectomy
Phase: Phase II | Study Chair: S Singhal and L. Martin

AFT-52: A phase II study of maintenance durvalumab vs durvalumab and olaparib +/- cediranib after front-line chemotherapy plus
durvalumab for extensive stage small cell lung cancer

Phase: Phase III | Study Chair: J. Sands

AFT-53: Multigroup AFT/NRG phase III trial of androgen deprivation therapy and potent androgen receptor pathway inhibition alone or with
177lu-Psma-617 In men with castration sensitive metastatic prostate cancer (MCSPC)

Phase: Phase III | Study Chair: S. Tagawa

ICARE data Integrating clinical trials and real-world endpoints, in collaboration with the MITRE Corporation
Study Chair: S. Piantadosi

ACTIVE AFT TRIALS
AFT-15: A phase I/II study of ibrutinib (PCI-32765) in combination with revlimid/dexamethasone (RD) in relapsed/refractory multiple myeloma
Phase: Phase I/II | Study Chairs: Y. Efebera and J. Laubach
Opened: 8/29/19

AFT-19/PRESTO: A phase 3 study of androgen annihilation in high-risk biochemically relapsed prostate cancer
Phase: Phase III | R. Aggarwal
Opened: 1/31/17

AFT-25/COMET: Comparison of operative to medical endocrine therapy (COMET) trial for low risk DCIS: A phase III prospective randomized trial
Phase: Phase III | Study Chairs: S. Hwang and A. Partridge
Opened: 2/22/17

AFT-27/ALEXANDRA/IMpassion030: A study comparing atezolizumab (anti PD-L1 antibody) in combination with adjuvant anthracycline/taxane-based chemotherapy versus chemotherapy alone in patients with operable triple-negative breast cancer (IMpassion030)
Phsae: Phase III | Study Chair: H. McArthur
Opened: 8/2/18

AFT-32: A phase II study of palbociclib in combination with ibrutinib in patients with previously treated mantle cell lymphoma
Phase: Phase II | Study Chair: K. Maddocks
Opened: 9/11/18

AFT-38/MBC-01/PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs. anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor positive (HR+)/HER2-positive metastatic
breast cancer

Phase: Phase III | Study Chair: O. Metzger
Opened: 3/1/17

AFT-41: A phase II study of ixazomib, lenalidomide, dexamethasone, and daratumumab in transplant-ineligible patients with newly diagnosed
multiple myeloma

Phase: Phase II | Study Chairs: E. O'Donnell and J. Laubach

AFT-42: Evaluation of the safety, activity and pharmacology of nivolumab in patients with advanced non-small cell lung cancer and preexisting
autoimmune disease

Phase: Phase I | Study Chair: R. Heist
Opened: 6/27/19

AFT-46: Chemotherapy combined with immune checkpoint inhibitor for operable stage IIIA/B non-small cell lung cancer
Phase: Phase II | Study Chairs: L. Martin, J. Patel and J. Urbanic
Opened: 9/1/19

AFT TRIALS IN FOLLOW-UP 
AFT-04/M14-011: A randomized, placebo-controlled, double-blind phase 3 study evaluating the safety and efficacy of the addition of velaparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy in subjects with early stage triple negative breast cancer (TNBC)
Phase: Phase III | Study Chair: M. Golshan
Opened: 4/2/14

AFT TRIALS CLOSED TO ENROLLMENT
AFT-05/PALLAS: Palbociclib collaborative adjuvant study: A randomized phase 3 trial of palbociclib with adjuvant endocrine therapy versus endocrine therapy alone for hormone receptor positive/HER2-negative breast cancer
Phase: Phase III | Study Chairs: E. Mayer and A. DeMichele
Opened: 8/31/15

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The TransPALLAS Committee announced on September 15, 2021, a Research Call for Investigators for the PALLAS study.
The following three documents provide more details about the research call:

Trans-PALLAS Overview Research Calls for Investigators
PALLAS-Research Proposal Checklist
PALLAS-Research Project Proposal Submission Form

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AFT-07/M14-360: A phase 1 dose escalation and phase 2 randomized, placebo-controlled study of the efficacy and tolerability of veliparib in combination with paclitaxel/carboplatin-based chemoradiotherapy followed by veliparib and paclitaxel/carboplatin consolidation in subjects with stage III non-small cell lung cancer (NSCLC)
Phase: Phase I/II | Study Chairs: J. Salama and T. Stinchcombe
Opened: 5/7/15

AFT-08/CC-486/DLBCL-001: A phase I, open-label, multi-center trial of oral azacitidine (CC-486) plus R-CHOP in subjects with high risk (IPI 3 or more) previously untreated diffuse large B-cell lymphoma or grade 3B follicular lymphoma
Phase: Phase I | Study Chair: P. Martin
Opened: 2/13/15

AFT-09: A randomized phase II trial evaluating the optimal sequencing of PD-1 inhibition with pembrolizumab (MK-3475) and standard platinum-based chemotherapy in patients with chemotherapy naive stage IV non-small cell lung cancer
Phase: Phase III | Study Chair: T. Hensing
Opened: 3/1/16

AFT-16: Phase II trial of induction immunotherapy with anti-PD-L1 for PD-L1 positive patients with unresectable stage IIIA and IIIB NSCLC eligible for chemoradiotherapy with curative intent
Phase: Phase II | Study Chair: H. Ross
Opened: 3/31/17

AFT-17: A randomized phase II study evaluating pembrolizumab vs topotecan in the second-line treatment of patients with small cell lung cancer
Phase: Phase II | Study Chair: T. Stinchcombe
Opened: 12/20/16

AFT-28/CANVAS: The benefits, harms and burdens of DOAC versus LMWH +/- warfarin for venous blood clots in cancer: A pragmatic randomized trial (CANVAS) - (randomized effectiveness trial)
Study Chairs; J. Connors and D. Schrag
Opened: 12/15/16

AFT-29: Phase 2, randomized, open-label study comparing daratumumab, lenalidomide, bortezomib, and dexamethasone (D-RVd) versus lenalidomide, bortezomib, and dexamethasone (RVd) in subjects with newly diagnosed multiple myeloma eligible for high-dose chemotherapy and autologous stem cell transplantation
Phase: Phase II | Study Chair: P. Voorhees
Opened: 8/1/16

AFT-31 Nivolumab with or without nab-paclitaxel in previously treated, advanced stage, non-small cell lung cancer: a randomized phase II Alliance study
Phase: Phase II | Study Chair: N. Ready
Opened: 12/1/16

AFT-39/PROTECT: Electronic patient reporting of symptoms during cancer treatment (PRO-TECT) - (randomized effectiveness trial)
Study Chair: E. Basch
Opened: 10/11/17

 

For more information about developing an AFT study, visit www.AllianceFoundationTrials.org.