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Clinical Trial News

MacroGenics' Vobra Duo Shows Promise in Metastatic Castration-Resistant Prostate Cancer

  • MacroGenics announced updated Phase 2 TAMARACK study data, showcasing vobramitamab duocarmazine's (vobra duo) encouraging antitumor activity in metastatic castration-resistant prostate cancer (mCRPC).
  • The study demonstrated a 6-month landmark radiographic progression-free survival (rPFS) rate of approximately 69-70% across both tested doses of vobra duo.
  • Vobra duo treatment was extended through a median of 6 doses, improving safety and tolerability compared to the Phase 1 mCRPC dose expansion cohort.
  • Mature median rPFS data is expected in early 2025, which will inform future development plans and potential partnering opportunities for vobra duo.

Opdivo and Yervoy Combo Shows 43% Survival Rate at 10 Years in Advanced Melanoma

• Bristol Myers Squibb's Opdivo and Yervoy combination therapy demonstrates a 43% survival rate in advanced melanoma patients after 10 years. • The median overall survival with the combination was 71.9 months, marking the longest reported in a Phase 3 advanced melanoma trial. • 64% of patients on the combination did not require subsequent systemic therapy at the 10-year follow-up, indicating durable benefit. • The CheckMate-067 trial's long-term data, presented at ESMO 2024, highlights a significant improvement in survival expectations for melanoma patients.

Oncternal Therapeutics Halts B-Cell Lymphoma Trial and Explores Strategic Alternatives

  • Oncternal Therapeutics discontinues its Phase 1/2 trial of ONCT-808, a CAR-T therapy targeting ROR1, for relapsed/refractory aggressive B-cell lymphoma due to strategic considerations.
  • The decision follows promising early antitumor activity of ONCT-808, including complete metabolic responses, but also a patient death at the highest dose tested.
  • Oncternal is also halting clinical trials for other pipeline candidates and reducing its workforce while exploring strategic options like asset sales or a merger.
  • The company cites disappointing early results from the ONCT-534 prostate cancer trial and a challenging financing environment as key factors in the decision.

Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax

NCT04501939Active, Not RecruitingPhase 2
University of California, San Diego
Posted 8/6/2020

TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

NCT02657005TerminatedPhase 1
Oncternal Therapeutics, Inc
Posted 8/1/2016

Study of Docetaxel Combined with Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer

NCT05156905TerminatedPhase 1
University of California, San Diego
Posted 6/16/2022

A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies

NCT03088878CompletedPhase 1
Oncternal Therapeutics, Inc
Posted 1/3/2018

A Clinical Study of ONCT-808 in Subjects With Relapsed or Refractory B-Cell Malignancies

NCT05588440TerminatedPhase 1
Oncternal Therapeutics, Inc
Posted 5/9/2023

A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.

NCT05917470TerminatedPhase 1
Oncternal Therapeutics, Inc
Posted 9/20/2023

FDA Approves AirPods Pro 2 as Over-the-Counter Hearing Aid

  • Apple's AirPods Pro 2 have received FDA approval as over-the-counter hearing aids, accessible via a software update later this year.
  • The approval allows AirPods Pro 2 users to enhance real-time sound, improving conversations and environmental awareness without needing traditional hearing aids.
  • The new feature aligns with the FDA's 2022 decision to allow over-the-counter hearing aids for adults with mild-to-moderate hearing loss.
  • AirPods Pro 2 include features like Active Hearing Protection and a self-administered Hearing Test, promoting hearing health awareness and monitoring.

Nivolumab and Ipilimumab Combination Shows Durable 10-Year Survival Benefit in Advanced Melanoma

  • The CheckMate 067 trial's 10-year data demonstrates a significant survival benefit for advanced melanoma patients treated with nivolumab plus ipilimumab.
  • Median overall survival reached 71.9 months with the combination therapy, compared to 19.9 months with ipilimumab alone, marking a substantial improvement.
  • Approximately half of the patients treated with the nivolumab and ipilimumab combination survived for 10 years or more, indicating a potential for long-term disease control.
  • The study found no new long-term safety concerns, suggesting the combination's tolerability supports its use as a durable treatment option.

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

NCT01844505CompletedPhase 3
Bristol-Myers Squibb
Posted 6/11/2013

A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)

NCT06246916RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 9/9/2024

Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma

NCT04949113Active, Not RecruitingPhase 3
The Netherlands Cancer Institute
Posted 7/8/2021

Rinatabart Sesutecan Shows Promise in Heavily Pretreated Ovarian Cancer

  • Rinatabart sesutecan (Rina-S) demonstrated a 50% confirmed objective response rate in heavily pretreated ovarian cancer patients at 120 mg/m2.
  • The Phase 1/2 study showed responses across all folate receptor-alpha (FRα) expression levels, suggesting broad applicability.
  • Genmab plans to initiate a Phase 3 trial in 2024 to further evaluate Rina-S in advanced ovarian cancer patients.
  • Common side effects were manageable, with infrequent dose reductions or discontinuations, supporting further development.

Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

NCT05579366RecruitingPhase 1
ProfoundBio US Co.
Posted 12/7/2022

Lantheus' 177Lu-PNT2002 Shows Promise in mCRPC Treatment: Phase 3 SPLASH Trial Results

  • Lantheus' 177Lu-PNT2002 significantly improved radiographic progression-free survival (rPFS) compared to ARPI in metastatic castration-resistant prostate cancer (mCRPC).
  • The SPLASH trial demonstrated a higher overall response rate (ORR) of 38.1% with 177Lu-PNT2002 versus 12.0% in the control arm.
  • Patients treated with 177Lu-PNT2002 experienced a statistically significant improvement in the time to reduction of health-related quality of life.
  • 177Lu-PNT2002 exhibited a favorable safety profile, with fewer treatment-emergent adverse events compared to the ARPI control arm.

Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

NCT04647526Active, Not RecruitingPhase 3
POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Posted 2/25/2021

Lantheus' 177Lu-PNT2002 Shows Promise in Metastatic Castration-Resistant Prostate Cancer

  • Lantheus' 177Lu-PNT2002 met its primary endpoint in the SPLASH Phase 3 trial, demonstrating a significant improvement in radiographic progression-free survival compared to ARPI switch.
  • The trial showed a 38.1% Overall Response Rate for 177Lu-PNT2002 versus 12.0% for the ARPI switch arm, including a 9.3% Complete Response rate.
  • Patients treated with 177Lu-PNT2002 experienced a statistically significant improvement in time to reduction of health-related quality of life.
  • Interim Overall Survival data, adjusted for crossover, showed a hazard ratio of <1.00, suggesting a potential survival benefit with 177Lu-PNT2002.

Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

NCT04647526Active, Not RecruitingPhase 3
POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Posted 2/25/2021

Long-Term Data Show Durable Benefit of Immunotherapy in Metastatic Melanoma

  • A decade-long follow-up of the CheckMate 067 trial reveals that roughly half of metastatic melanoma patients treated with nivolumab and ipilimumab remain cancer-free.
  • The combination therapy demonstrates a sustained efficacy and safety profile, with no new long-term toxicity signals observed over the 10-year period.
  • The findings suggest that patients progression-free at three years have a high likelihood of remaining alive and disease-free at the 10-year mark.
  • Researchers suggest the long-term success may allow for reduced follow-up frequency for patients doing well after three to five years.

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