A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors

Conditions

• Colorectal Adenocarcinoma
• Melanoma
• Non Small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Papillary Thyroid Cancer
• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CM-24 and Nivolumab - Dose Escalation — DRUG
  Dose escalation of CM24 with nivolumab in adult patients with selected recurrent or metastatic solid tumors
• CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion — DRUG
  Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer
• CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion — DRUG
  Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer
• Nivolumab, Nab paclitaxel and Gemcitabine - Expansion — DRUG
  Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer
• Nivolumab and Nal-IRI/5-FU/LV - Expansion — DRUG
  Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer

Study Details

This is an open-label, multicenter, multi-dose escalation and dose expansion study in subjects with selected advanced solid tumors (Part A) and advanced metastatic pancreatic cancer (Parts C \& D) to evaluate the safety and tolerability of CM-24 in combination with nivolumab. In Part C of the study gemcitabine/nab-paclitaxel or Nal-IRI/5-FU/LV will be administered subsequent to CM24 and nivolumab. CM24, nivolumab and gemcitabine/nab-paclitaxel or Nal-IRI/5-FU/LV are administered intravenously.

Key Dates

Start date

Mar 19, 2021

Status verified

Jun 2024

Primary completion

Sep 30, 2024

Completion

Sep 30, 2024

Study Design

Enrollment

79 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A- Dose escalation of CM24 in combination with nivolumab
• Experimental: Part C- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine
• Experimental: Part C- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV
• Experimental: Part D- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine
• Experimental: Part D- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV
• Active Comparator: Part D- Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine
• Active Comparator: Part D- Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV

Primary Outcome Measure

Part A: Incidence of treatment emergent adverse events [ Time Frame: Up to 24 months ]

Locations (5)

Find similar trials in Scottsdale, AZ

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